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Innolitics
Anesthesiology
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Hematology
Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Miscellaneous
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
HDO
Valve, Tubal Occlusion
3
Product Code
HDR
Cap, Cervical
2
Product Code
HDT
Device, Intrauterine, Contraceptive And Introducer
3
Product Code
HDW
Diaphragm, Contraceptive (And Accessories)
2
Product Code
HEB
Tampon, Menstrual, Unscented
2
Product Code
K
24
0708
Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
2
Cleared 510(K)
K
23
2060
TOSAMA Reusable Applicator
2
Cleared 510(K)
K
23
2598
Unscented Menstrual Tampon
2
Cleared 510(K)
K
22
3883
Daye Tampon
2
Cleared 510(K)
K
23
1341
Organic cotton tampon, Viscose tampon
2
Cleared 510(K)
K
23
0419
Sequel Tampon with Plastic Applicator
2
Cleared 510(K)
K
22
3749
U by Kotex® Click® Unscented Menstrual Tampons
2
Cleared 510(K)
K
22
2046
Unscented Menstrual Tampon
2
Cleared 510(K)
K
21
2277
Tempo Tampon
2
Cleared 510(K)
K
22
0238
Cohitech Cottonlock Tampons with Reusable Applicator
2
Cleared 510(K)
K
21
1775
Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
2
Cleared 510(K)
K
21
2479
Cohitech Reusable Tampon Applicator
2
Cleared 510(K)
K
21
2272
Tempo Natural Tampon
2
Cleared 510(K)
K
21
2304
Callaly Tampliner (super plus absorbency)
2
Cleared 510(K)
K
21
1519
Every Cycle Reusable Tampon Applicator
2
Cleared 510(K)
K
21
1469
Callaly Tampliner
2
Cleared 510(K)
K
20
1003
Callaly Tampliner
2
Cleared 510(K)
K
19
2557
Youjia Unscented Tampon with Plastic Applicators
2
Cleared 510(K)
K
19
1666
Unscented W long plastic and cardboard applicator tampons
2
Cleared 510(K)
K
19
1431
Interlude Rolled Tampons in Plastic Applicator
2
Cleared 510(K)
K
18
2142
FEMME Applicator Tampon
2
Cleared 510(K)
K
18
2817
CottonDay Tampon
2
Cleared 510(K)
K
18
2814
Rael Tampon
2
Cleared 510(K)
K
19
0218
Unscented Menstrual Tampon
2
Cleared 510(K)
K
18
2813
COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
2
Cleared 510(K)
K
18
1911
Interlude 100% Cotton Tampon
2
Cleared 510(K)
K
18
0850
re.t.a Reuseable Tampon Applicator
2
Cleared 510(K)
K
17
3225
Interlude and private label Unscented 3-piece compact applicator tampon
2
Cleared 510(K)
K
18
0167
Playtex Stella Tampons
2
Cleared 510(K)
K
17
2504
Tosama Biobased Applicator Tube Menstrual Tampon
2
Cleared 510(K)
K
17
2118
U by Kotex Click Unscented Menstrual Tampons
2
Cleared 510(K)
K
16
2746
Ontex and other proprietary names
2
Cleared 510(K)
K
16
1877
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl
2
Cleared 510(K)
K
15
2284
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
2
Cleared 510(K)
K
15
1470
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency
2
Cleared 510(K)
K
15
1170
Tosama 100% Organic Cotton Menstrual Tampon
2
Cleared 510(K)
K
14
2786
Ontex Unscented Tampons with Colored Plastic Applicators
2
Cleared 510(K)
K
15
0897
Tosama 100% Cotton Menstrual Tampon
2
Cleared 510(K)
K
14
0077
ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
2
Cleared 510(K)
K
14
1294
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
2
Cleared 510(K)
K
13
2595
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
2
Cleared 510(K)
K
13
3244
TAMPAX M PLASTIC TAMPONS, UNSCENTED
2
Cleared 510(K)
K
13
1543
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
2
Cleared 510(K)
K
13
0609
VEEDA 100% COTTON MENSTRUAL TAMPON
2
Cleared 510(K)
K
12
2603
ONTEX AND OTHER PROPRIETARY NAMES
2
Cleared 510(K)
K
12
0481
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
2
Cleared 510(K)
K
11
3699
TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
2
Cleared 510(K)
K
11
3036
U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
2
Cleared 510(K)
K
11
2635
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
2
Cleared 510(K)
K
11
0669
TAMPAX C PLASTIC TAMPONS, UNSCENTED
2
Cleared 510(K)
K
10
3311
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
2
Cleared 510(K)
K
10
2445
ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
09
1281
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
2
Cleared 510(K)
K
09
1749
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
2
Cleared 510(K)
K
09
0819
ONTEX TAMPON (UNSCENTED)
2
Cleared 510(K)
K
09
2054
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
2
Cleared 510(K)
K
09
0071
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
09
1084
MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
2
Cleared 510(K)
K
08
0733
COTTONS 100% NATURAL COTTON TAMPONS
2
Cleared 510(K)
K
09
0098
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
2
Cleared 510(K)
K
08
0775
MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
2
Cleared 510(K)
K
06
2001
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
06
2638
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
2
Cleared 510(K)
K
06
1486
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
2
Cleared 510(K)
K
05
1290
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)
2
Cleared 510(K)
K
05
0660
FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
04
0999
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
2
Cleared 510(K)
K
03
0474
PH BUFFERING PLASTIC APPLICATOR TAMPON
2
Cleared 510(K)
K
03
2636
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
2
Cleared 510(K)
K
03
1067
FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS
2
Cleared 510(K)
K
02
3789
O.B. TAMPONS
2
Cleared 510(K)
K
02
3479
FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES
2
Cleared 510(K)
K
02
0535
INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
99
2493
VIPON TAMPON
2
Cleared 510(K)
K
00
2096
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR
2
Cleared 510(K)
K
00
1641
TAMPONS
2
Cleared 510(K)
K
99
3794
PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
2
Cleared 510(K)
K
99
0536
O.B. TAMPON
2
Cleared 510(K)
K
99
1118
O.B. APPLICATOR TAMPONS, O.B. TAMPONS
2
Cleared 510(K)
K
98
3478
ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
2
Cleared 510(K)
K
98
3381
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
2
Cleared 510(K)
K
98
1953
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
2
Cleared 510(K)
K
98
1760
PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
2
Cleared 510(K)
K
98
0478
PLAYTEX TAMPONS #03498
2
Cleared 510(K)
K
97
4629
O.B. APPLICATOR AND NON-APPLICATOR TAMPONS
2
Cleared 510(K)
K
97
0954
O.B. APPLICATOR TAMPONS
2
Cleared 510(K)
K
97
1174
PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS
2
Cleared 510(K)
K
97
1228
FEMTEX 100% COTTON TAMPONS
2
Cleared 510(K)
K
97
0108
HARMONIES MENSTRUAL TAMPON
2
Cleared 510(K)
K
97
0232
FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
2
Cleared 510(K)
K
96
5064
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
2
Cleared 510(K)
K
96
3034
FEMTEX GENTLE TOUCH TAMPONS
2
Cleared 510(K)
K
96
3032
FREE CHOICE
2
Cleared 510(K)
K
96
2712
YSANPOINT) (MENSTRUAL) DIGITAL TAMPON
2
Cleared 510(K)
K
96
2476
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
2
Cleared 510(K)
K
96
1926
SANPOINT MENSTRUAL TAMPON
2
Cleared 510(K)
K
96
0341
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
2
Cleared 510(K)
K
95
4445
NON APPLICATOR TAMPON, UNTREATED
2
Cleared 510(K)
K
95
4942
NATRACAREN APPLICATOR TAMPON
2
Cleared 510(K)
K
95
3333
MENSTRUAL TAMPON
2
Cleared 510(K)
K
95
0194
TAMPON, UNTREATED
2
Cleared 510(K)
K
95
2394
PLAYTEX TAMPONS #13695
2
Cleared 510(K)
K
95
1924
ORGANIC TAMPONS
2
Cleared 510(K)
K
94
4155
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094
2
Cleared 510(K)
K
94
4154
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994
2
Cleared 510(K)
K
94
4064
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894
2
Cleared 510(K)
K
94
4834
UNSCENTED MENSTRUAL TAMPONS
2
Cleared 510(K)
K
94
1936
UNSCENTED MENSTRUAL TAMPON
2
Cleared 510(K)
K
94
2418
PLAYTEX TAMPONS MODEL 13794
2
Cleared 510(K)
K
94
1863
O.B. TAMPON
2
Cleared 510(K)
K
93
0400
TERRA FEMME
2
Cleared 510(K)
K
93
0149
KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+
2
Cleared 510(K)
K
91
4430
NATRACARE TAMPON
2
Cleared 510(K)
K
92
0238
PRIVATE LABELS AND FEMTEX
2
Cleared 510(K)
K
92
4303
TAMPAX TAMPON, REGULAR ABSORBENCY
2
Cleared 510(K)
K
92
3932
TAMPAX TAMPONS, SUPER ABSORBENCY
2
Cleared 510(K)
K
92
3985
UNSCENTED MENSTRUAL TAMPON
2
Cleared 510(K)
K
91
2941
TAMPON, UNTREATED
2
Cleared 510(K)
K
91
2552
UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR
2
Cleared 510(K)
K
90
4937
PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS
2
Cleared 510(K)
K
89
7007
UNSCENTED MENSTRUAL TAMPON
2
Cleared 510(K)
K
89
7008
MENSTRUAL TAMPON
2
Cleared 510(K)
K
89
6989
TAMPAX TAMPON
2
Cleared 510(K)
K
89
6994
KOTEX SECURITY TAMPONS (SEVERAL TYPE)
2
Cleared 510(K)
K
89
6112
TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS
2
Cleared 510(K)
K
89
6113
TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS
2
Cleared 510(K)
K
89
6114
TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB.
2
Cleared 510(K)
K
89
4846
UNSCENTED MENSTRUAL TAMPON
2
Cleared 510(K)
K
89
3725
PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT
2
Cleared 510(K)
K
88
5194
KOTEX SECURITY TUBE TAMPONS
2
Cleared 510(K)
K
88
1384
INTERLABIAL PAD
2
Cleared 510(K)
K
88
4305
KOTEX STICK TAMPONS, REGULAR AND SUPER
2
Cleared 510(K)
K
88
3867
CERVICAL BIOPSY INSTRUMENT
2
Cleared 510(K)
K
87
1715
ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONS
2
Cleared 510(K)
K
87
2018
KOTEX STICK TAMPONS, REGULAR AND SUPER
2
Cleared 510(K)
K
87
1642
TAMPAX TAMPON, REGULAR
2
Cleared 510(K)
K
87
0539
O.B. SLENDER REGULAR TAMPON
2
Cleared 510(K)
K
86
4859
SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS
2
Cleared 510(K)
K
86
4651
SUPER TAMPONS
2
Cleared 510(K)
K
86
4650
SLENDER REGULAR TAMPONS
2
Cleared 510(K)
K
86
4649
REGULAR PETAL SOFT PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
86
4648
SUPER PLUS PETAL SOFT PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
86
4652
SUPER PLUS TAMPONS
2
Cleared 510(K)
K
87
0359
TAMPAX CLOSED-END FLUSHABLE TAMPON, ORIG. REGULAR
2
Cleared 510(K)
K
87
0360
TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER PLUS
2
Cleared 510(K)
K
87
0358
TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER
2
Cleared 510(K)
K
87
0361
TAMPAX CLOSED-END FLUSHABLE TAMPON, SLENDER REGU.
2
Cleared 510(K)
K
86
4750
KOTEX SECURITY TAMPONS, REGULAR AND SUPER
2
Cleared 510(K)
K
86
3464
TAMPAX SUPER TAMPONS
2
Cleared 510(K)
K
86
1911
SUPER PLUS PETAL SOFT PLASTIC APPLI. TAMPAX TAMPON
2
Cleared 510(K)
K
86
1913
SLENDER REGULAR TAMPAX TAMPONS
2
Cleared 510(K)
K
86
1912
SUPER PLUS TAMPAX TAMPONS
2
Cleared 510(K)
K
86
1910
SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS
2
Cleared 510(K)
K
86
1909
REGULAR PETAL SOFT PLASTIC APPLI. TAMPAX TAMPONS
2
Cleared 510(K)
K
86
1908
TAMPAX ORIGINAL REGULAR TAMPON
2
Cleared 510(K)
K
86
1907
TAMPAX SUPER TAMPONS
2
Cleared 510(K)
K
86
1906
TAMPAX JUNIOR TAMPONS
2
Cleared 510(K)
K
85
3192
KOTEX SECURITY TUBE TAMPON
2
Cleared 510(K)
K
85
1941
UNSCENTED MENSTRUAL TAMPONS
2
Cleared 510(K)
K
85
2063
PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS
2
Cleared 510(K)
K
85
1355
PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS
2
Cleared 510(K)
K
85
1356
PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS
2
Cleared 510(K)
K
84
4935
ORIGINAL REGULAR TAMPAX TAMPONS
2
Cleared 510(K)
K
84
4936
SUPER TAMPAX TAMPONS
2
Cleared 510(K)
K
84
2618
SUPER PETAL SOFT PLASTIC APPLICATOR TAMP
2
Cleared 510(K)
K
84
2619
REGULAR PETAL SOFT PLASTIC APPLICATOR
2
Cleared 510(K)
K
83
2818
UNSCENTED MENSTRUAL TAMPON
2
Cleared 510(K)
K
83
3179
O.B. TAMPONS
2
Cleared 510(K)
K
82
0174
TAMPAX TAMPONS
2
Cleared 510(K)
K
81
3642
PETAL SOFT PLASTIC APPLICATOR TAMPAX
2
Cleared 510(K)
K
81
2870
IMPROVED PLAYTEX TAMPON
2
Cleared 510(K)
K
81
1385
PLAYTEX DIGITAL TAMPON
2
Cleared 510(K)
K
81
1388
PLAYTEX COTTON DIGITAL TAMPON
2
Cleared 510(K)
K
81
1992
ASSURE NATURAL FIT TAMPON
2
Cleared 510(K)
K
81
1983
JOHNSON & JOHNSON O.B. TAMPONS
2
Cleared 510(K)
K
80
2760
PETAL SOFT PLASTIC APPLICATOR TAMPAX
2
Cleared 510(K)
K
80
2193
KOTEX SECURITY TUBE TAMPONS
2
Cleared 510(K)
K
80
0777
TAMPAX TAMPONS
2
Cleared 510(K)
K
79
1274
RELY TAMPON
2
Cleared 510(K)
K
79
0385
KOTEX TUBE AND STICK TAMPON
2
Cleared 510(K)
K
78
0648
MODIFIED UNTREATED TAMPAX TAMPONS
2
Cleared 510(K)
K
78
0243
TAMPON, RELY MODIFIED
2
Cleared 510(K)
HEC
Insufflator, Vaginal
1
Product Code
HED
Douche Apparatus, Vaginal, Therapeutic
1
Product Code
HEE
Set, Anesthesia, Paracervical
2
Product Code
HEG
Set, Anesthesia, Pudendal
2
Product Code
HEH
Chamber, Decompression, Abdominal
3
Product Code
HFY
Band, Tubal Occlusion
3
Product Code
HGB
Clip, Tubal Occlusion
3
Product Code
HGF
Source, Abortion Unit, Vacuum
2
Product Code
HGG
Controller, Abortion Unit, Vacuum
2
Product Code
HGH
Cannula, Suction, Uterine
2
Product Code
HGX
Pump, Breast, Powered
2
Product Code
HGY
Pump, Breast, Non-Powered
1
Product Code
HGZ
Heater, Perineal, Direct Contact
2
Product Code
HHA
Heater, Perineal, Radiant, Non-Contact
2
Product Code
HHD
Pad, Menstrual, Unscented
1
Product Code
HHE
Cup, Menstrual
2
Product Code
HHI
System, Abortion, Vacuum
2
Product Code
HHL
Pad, Menstrual, Scented
2
Product Code
HHQ
System, Abortion, Metreurynter-Balloon
3
Product Code
HHS
Transcervical Contraceptive Tubal Occlusion Device
3
Product Code
HII
Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
3
Product Code
HIL
Tampon, Menstrual, Scented, Deodorized
2
Product Code
HIS
Condom
2
Product Code
KND
Heater, Perineal
2
Product Code
KNE
Set, Anesthesia, Obstetric
2
Product Code
KNH
Laparoscopic Contraceptive Tubal Occlusion Device
3
Product Code
KXQ
Vibrator For Therapeutic Use, Genital
2
Product Code
LTZ
Condom With Nonoxynol-9
2
Product Code
LZL
Micro-Condom
3
Product Code
MBU
Single-Use Internal Condom
2
Product Code
MFD
Cannula, Intrauterine Insemination
2
Product Code
NUR
Pad, Interlabial
1
Product Code
MOL
Condom, Synthetic
2
Product Code
MSC
Barrier, Std, Oral Sex
2
Product Code
NBV
Device, Engorgement, Clitoral
2
Product Code
NRC
Pads, Menstrual, Scented-Deodorized
1
Product Code
NUC
Lubricant, Personal
2
Product Code
NUQ
Pad, Menstrual, Reusable
1
Product Code
OBB
Kit, Conception-Assist, Home Use
2
Product Code
OBY
Condom, Female, Animal Tissue
3
Product Code
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
2
Product Code
OHH
Breast Pump Kit
2
Product Code
OKW
Seminal Fluid Collection Kit
2
Product Code
OOA
Hemorrhoid Prevention Pressure Wedge
2
Product Code
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
3
Product Code
PAI
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
3
Product Code
PNU
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
2
Product Code
PVT
Maternity Kit
1
Product Code
PVU
Obstetrical Anesthesia Kit
2
Product Code
PVV
Paracervical Anesthesia Kit
2
Product Code
PVW
Pudendal Anesthesia Kit
2
Product Code
PWA
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
1
Product Code
PYT
Device, Fertility Diagnostic, Contraceptive, Software Application
2
Product Code
QPD
Personal Lubricant Ring
2
Product Code
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
OB
/
subpart-f—obstetrical-and-gynecological-therapeutic-devices
/
HEB
/
K970954
View Source
O.B. APPLICATOR TAMPONS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K970954
510(k) Type
Traditional
Applicant
PERSONAL PRODUCTS CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/1997
Days to Decision
85 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
HDO
Valve, Tubal Occlusion
HDR
Cap, Cervical
HDT
Device, Intrauterine, Contraceptive And Introducer
HDW
Diaphragm, Contraceptive (And Accessories)
HEB
Tampon, Menstrual, Unscented
K
24
0708
Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
K
23
2060
TOSAMA Reusable Applicator
K
23
2598
Unscented Menstrual Tampon
K
22
3883
Daye Tampon
K
23
1341
Organic cotton tampon, Viscose tampon
K
23
0419
Sequel Tampon with Plastic Applicator
K
22
3749
U by Kotex® Click® Unscented Menstrual Tampons
K
22
2046
Unscented Menstrual Tampon
K
21
2277
Tempo Tampon
K
22
0238
Cohitech Cottonlock Tampons with Reusable Applicator
K
21
1775
Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
K
21
2479
Cohitech Reusable Tampon Applicator
K
21
2272
Tempo Natural Tampon
K
21
2304
Callaly Tampliner (super plus absorbency)
K
21
1519
Every Cycle Reusable Tampon Applicator
K
21
1469
Callaly Tampliner
K
20
1003
Callaly Tampliner
K
19
2557
Youjia Unscented Tampon with Plastic Applicators
K
19
1666
Unscented W long plastic and cardboard applicator tampons
K
19
1431
Interlude Rolled Tampons in Plastic Applicator
K
18
2142
FEMME Applicator Tampon
K
18
2817
CottonDay Tampon
K
18
2814
Rael Tampon
K
19
0218
Unscented Menstrual Tampon
K
18
2813
COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
K
18
1911
Interlude 100% Cotton Tampon
K
18
0850
re.t.a Reuseable Tampon Applicator
K
17
3225
Interlude and private label Unscented 3-piece compact applicator tampon
K
18
0167
Playtex Stella Tampons
K
17
2504
Tosama Biobased Applicator Tube Menstrual Tampon
K
17
2118
U by Kotex Click Unscented Menstrual Tampons
K
16
2746
Ontex and other proprietary names
K
16
1877
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl
K
15
2284
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
K
15
1470
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency
K
15
1170
Tosama 100% Organic Cotton Menstrual Tampon
K
14
2786
Ontex Unscented Tampons with Colored Plastic Applicators
K
15
0897
Tosama 100% Cotton Menstrual Tampon
K
14
0077
ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
K
14
1294
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
K
13
2595
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
K
13
3244
TAMPAX M PLASTIC TAMPONS, UNSCENTED
K
13
1543
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
K
13
0609
VEEDA 100% COTTON MENSTRUAL TAMPON
K
12
2603
ONTEX AND OTHER PROPRIETARY NAMES
K
12
0481
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
K
11
3699
TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
K
11
3036
U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
K
11
2635
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
K
11
0669
TAMPAX C PLASTIC TAMPONS, UNSCENTED
K
10
3311
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
K
10
2445
ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
K
09
1281
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
K
09
1749
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
K
09
0819
ONTEX TAMPON (UNSCENTED)
K
09
2054
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
K
09
0071
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
K
09
1084
MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
K
08
0733
COTTONS 100% NATURAL COTTON TAMPONS
K
09
0098
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
K
08
0775
MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
K
06
2001
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
K
06
2638
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
K
06
1486
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
K
05
1290
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)
K
05
0660
FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K
04
0999
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
K
03
0474
PH BUFFERING PLASTIC APPLICATOR TAMPON
K
03
2636
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
K
03
1067
FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS
K
02
3789
O.B. TAMPONS
K
02
3479
FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES
K
02
0535
INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K
99
2493
VIPON TAMPON
K
00
2096
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR
K
00
1641
TAMPONS
K
99
3794
PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
K
99
0536
O.B. TAMPON
K
99
1118
O.B. APPLICATOR TAMPONS, O.B. TAMPONS
K
98
3478
ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
K
98
3381
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
K
98
1953
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
K
98
1760
PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
K
98
0478
PLAYTEX TAMPONS #03498
K
97
4629
O.B. APPLICATOR AND NON-APPLICATOR TAMPONS
K
97
0954
O.B. APPLICATOR TAMPONS
K
97
1174
PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS
K
97
1228
FEMTEX 100% COTTON TAMPONS
K
97
0108
HARMONIES MENSTRUAL TAMPON
K
97
0232
FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
K
96
5064
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
K
96
3034
FEMTEX GENTLE TOUCH TAMPONS
K
96
3032
FREE CHOICE
K
96
2712
YSANPOINT) (MENSTRUAL) DIGITAL TAMPON
K
96
2476
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K
96
1926
SANPOINT MENSTRUAL TAMPON
K
96
0341
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K
95
4445
NON APPLICATOR TAMPON, UNTREATED
K
95
4942
NATRACAREN APPLICATOR TAMPON
K
95
3333
MENSTRUAL TAMPON
K
95
0194
TAMPON, UNTREATED
K
95
2394
PLAYTEX TAMPONS #13695
K
95
1924
ORGANIC TAMPONS
K
94
4155
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094
K
94
4154
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994
K
94
4064
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894
K
94
4834
UNSCENTED MENSTRUAL TAMPONS
K
94
1936
UNSCENTED MENSTRUAL TAMPON
K
94
2418
PLAYTEX TAMPONS MODEL 13794
K
94
1863
O.B. TAMPON
K
93
0400
TERRA FEMME
K
93
0149
KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+
K
91
4430
NATRACARE TAMPON
K
92
0238
PRIVATE LABELS AND FEMTEX
K
92
4303
TAMPAX TAMPON, REGULAR ABSORBENCY
K
92
3932
TAMPAX TAMPONS, SUPER ABSORBENCY
K
92
3985
UNSCENTED MENSTRUAL TAMPON
K
91
2941
TAMPON, UNTREATED
K
91
2552
UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR
K
90
4937
PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS
K
89
7007
UNSCENTED MENSTRUAL TAMPON
K
89
7008
MENSTRUAL TAMPON
K
89
6989
TAMPAX TAMPON
K
89
6994
KOTEX SECURITY TAMPONS (SEVERAL TYPE)
K
89
6112
TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS
K
89
6113
TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS
K
89
6114
TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB.
K
89
4846
UNSCENTED MENSTRUAL TAMPON
K
89
3725
PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT
K
88
5194
KOTEX SECURITY TUBE TAMPONS
K
88
1384
INTERLABIAL PAD
K
88
4305
KOTEX STICK TAMPONS, REGULAR AND SUPER
K
88
3867
CERVICAL BIOPSY INSTRUMENT
K
87
1715
ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONS
K
87
2018
KOTEX STICK TAMPONS, REGULAR AND SUPER
K
87
1642
TAMPAX TAMPON, REGULAR
K
87
0539
O.B. SLENDER REGULAR TAMPON
K
86
4859
SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS
K
86
4651
SUPER TAMPONS
K
86
4650
SLENDER REGULAR TAMPONS
K
86
4649
REGULAR PETAL SOFT PLASTIC APPLICATOR TAMPONS
K
86
4648
SUPER PLUS PETAL SOFT PLASTIC APPLICATOR TAMPONS
K
86
4652
SUPER PLUS TAMPONS
K
87
0359
TAMPAX CLOSED-END FLUSHABLE TAMPON, ORIG. REGULAR
K
87
0360
TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER PLUS
K
87
0358
TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER
K
87
0361
TAMPAX CLOSED-END FLUSHABLE TAMPON, SLENDER REGU.
K
86
4750
KOTEX SECURITY TAMPONS, REGULAR AND SUPER
K
86
3464
TAMPAX SUPER TAMPONS
K
86
1911
SUPER PLUS PETAL SOFT PLASTIC APPLI. TAMPAX TAMPON
K
86
1913
SLENDER REGULAR TAMPAX TAMPONS
K
86
1912
SUPER PLUS TAMPAX TAMPONS
K
86
1910
SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS
K
86
1909
REGULAR PETAL SOFT PLASTIC APPLI. TAMPAX TAMPONS
K
86
1908
TAMPAX ORIGINAL REGULAR TAMPON
K
86
1907
TAMPAX SUPER TAMPONS
K
86
1906
TAMPAX JUNIOR TAMPONS
K
85
3192
KOTEX SECURITY TUBE TAMPON
K
85
1941
UNSCENTED MENSTRUAL TAMPONS
K
85
2063
PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS
K
85
1355
PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS
K
85
1356
PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS
K
84
4935
ORIGINAL REGULAR TAMPAX TAMPONS
K
84
4936
SUPER TAMPAX TAMPONS
K
84
2618
SUPER PETAL SOFT PLASTIC APPLICATOR TAMP
K
84
2619
REGULAR PETAL SOFT PLASTIC APPLICATOR
K
83
2818
UNSCENTED MENSTRUAL TAMPON
K
83
3179
O.B. TAMPONS
K
82
0174
TAMPAX TAMPONS
K
81
3642
PETAL SOFT PLASTIC APPLICATOR TAMPAX
K
81
2870
IMPROVED PLAYTEX TAMPON
K
81
1385
PLAYTEX DIGITAL TAMPON
K
81
1388
PLAYTEX COTTON DIGITAL TAMPON
K
81
1992
ASSURE NATURAL FIT TAMPON
K
81
1983
JOHNSON & JOHNSON O.B. TAMPONS
K
80
2760
PETAL SOFT PLASTIC APPLICATOR TAMPAX
K
80
2193
KOTEX SECURITY TUBE TAMPONS
K
80
0777
TAMPAX TAMPONS
K
79
1274
RELY TAMPON
K
79
0385
KOTEX TUBE AND STICK TAMPON
K
78
0648
MODIFIED UNTREATED TAMPAX TAMPONS
K
78
0243
TAMPON, RELY MODIFIED
HEC
Insufflator, Vaginal
HED
Douche Apparatus, Vaginal, Therapeutic
HEE
Set, Anesthesia, Paracervical
HEG
Set, Anesthesia, Pudendal
HEH
Chamber, Decompression, Abdominal
HFY
Band, Tubal Occlusion
HGB
Clip, Tubal Occlusion
HGF
Source, Abortion Unit, Vacuum
HGG
Controller, Abortion Unit, Vacuum
HGH
Cannula, Suction, Uterine
HGX
Pump, Breast, Powered
HGY
Pump, Breast, Non-Powered
HGZ
Heater, Perineal, Direct Contact
HHA
Heater, Perineal, Radiant, Non-Contact
HHD
Pad, Menstrual, Unscented
HHE
Cup, Menstrual
HHI
System, Abortion, Vacuum
HHL
Pad, Menstrual, Scented
HHQ
System, Abortion, Metreurynter-Balloon
HHS
Transcervical Contraceptive Tubal Occlusion Device
HII
Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
HIL
Tampon, Menstrual, Scented, Deodorized
HIS
Condom
KND
Heater, Perineal
KNE
Set, Anesthesia, Obstetric
KNH
Laparoscopic Contraceptive Tubal Occlusion Device
KXQ
Vibrator For Therapeutic Use, Genital
LTZ
Condom With Nonoxynol-9
LZL
Micro-Condom
MBU
Single-Use Internal Condom
MFD
Cannula, Intrauterine Insemination
NUR
Pad, Interlabial
MOL
Condom, Synthetic
MSC
Barrier, Std, Oral Sex
NBV
Device, Engorgement, Clitoral
NRC
Pads, Menstrual, Scented-Deodorized
NUC
Lubricant, Personal
NUQ
Pad, Menstrual, Reusable
OBB
Kit, Conception-Assist, Home Use
OBY
Condom, Female, Animal Tissue
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
OHH
Breast Pump Kit
OKW
Seminal Fluid Collection Kit
OOA
Hemorrhoid Prevention Pressure Wedge
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
PAI
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
PNU
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
PVT
Maternity Kit
PVU
Obstetrical Anesthesia Kit
PVV
Paracervical Anesthesia Kit
PVW
Pudendal Anesthesia Kit
PWA
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
PYT
Device, Fertility Diagnostic, Contraceptive, Software Application
QPD
Personal Lubricant Ring
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-f—obstetrical-and-gynecological-therapeutic-devices
/
HEB
/
K970954
View Source
O.B. APPLICATOR TAMPONS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K970954
510(k) Type
Traditional
Applicant
PERSONAL PRODUCTS CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/1997
Days to Decision
85 days
Submission Type
Summary