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Review Panel
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Review Panel
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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
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
K
13
2208
ONTEX AND OTHERS PROPRIETARY NAMES
2
Cleared 510(K)
K
13
2819
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
2
Cleared 510(K)
K
12
0245
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
2
Cleared 510(K)
K
11
1684
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
2
Cleared 510(K)
K
08
1555
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
2
Cleared 510(K)
K
07
3662
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
2
Cleared 510(K)
K
07
2376
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
2
Cleared 510(K)
K
07
0745
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
2
Cleared 510(K)
K
06
0981
PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
2
Cleared 510(K)
K
05
1446
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
05
0067
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
04
2773
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
04
0312
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
2
Cleared 510(K)
K
03
2173
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
03
2080
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
2
Cleared 510(K)
K
02
2882
MODIFICATION TO PLAYTEX TAMPONS #24002
2
Cleared 510(K)
K
02
0200
PLAYTEX DEODORANT TAMPONS, MODEL 34802
2
Cleared 510(K)
K
02
0202
PLAYTEX DEODORANT TAMPONS, MODEL 34702
2
Cleared 510(K)
K
02
0201
PLAYTEX DEODORANT TAMPONS, MODEL 34902
2
Cleared 510(K)
K
01
1996
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
2
Cleared 510(K)
K
01
1171
TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS
2
Cleared 510(K)
K
98
2383
PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS
2
Cleared 510(K)
K
97
1547
PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS
2
Cleared 510(K)
K
96
4269
PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
2
Cleared 510(K)
K
96
1870
PLAYTEX SLIMFIT TAMPONS
2
Cleared 510(K)
K
96
1456
PLAYTEX TAMPONS #10296
2
Cleared 510(K)
K
95
3638
O.B. APPLICATOR TAMPONS
2
Cleared 510(K)
K
95
2344
SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS
2
Cleared 510(K)
K
95
0928
ULTIMATES SILK GLIDE TAMPONS
2
Cleared 510(K)
K
94
1044
PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194
2
Cleared 510(K)
K
94
1196
PLATEX TAMPONS MODEL NUMBER 07094
2
Cleared 510(K)
K
94
0821
PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED
2
Cleared 510(K)
K
93
6189
PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED
2
Cleared 510(K)
K
93
5276
PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS
2
Cleared 510(K)
K
93
4083
PLAYTEX ULTIMATES TAMPONS
2
Cleared 510(K)
K
93
2909
PLAYTEX ULTIMATES TAMPONS
2
Cleared 510(K)
K
93
2907
PLAYTEX ULTIMATES TAMPONS
2
Cleared 510(K)
K
92
2834
TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY
2
Cleared 510(K)
K
92
4279
PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER +
2
Cleared 510(K)
K
91
4438
PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS
2
Cleared 510(K)
K
91
2002
PLAYTEX NON-DEODORANT/DEODORANT TAMPONS
2
Cleared 510(K)
K
90
5378
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS
2
Cleared 510(K)
K
89
7012
SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS
2
Cleared 510(K)
K
89
6115
TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER
2
Cleared 510(K)
K
89
1297
PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS
2
Cleared 510(K)
K
88
4737
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS
2
Cleared 510(K)
K
88
1057
PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER
2
Cleared 510(K)
K
88
0024
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS
2
Cleared 510(K)
K
88
0023
TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON
2
Cleared 510(K)
K
88
0022
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON
2
Cleared 510(K)
K
87
3457
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
2
Cleared 510(K)
K
87
4509
PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL
2
Cleared 510(K)
K
87
2261
TAMPAX DEODORANT TAMPON, SUPER
2
Cleared 510(K)
K
87
2258
TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER PLUS
2
Cleared 510(K)
K
87
2259
TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER
2
Cleared 510(K)
K
87
2260
TAMPAX DEODORANT TAMPON, SLENDER REGULAR
2
Cleared 510(K)
K
87
2256
TAMPAX DEODORANT TAMPON, ORIGINAL REGULAR
2
Cleared 510(K)
K
87
2255
TAMPAX DEODORANT TAMPON, SUPER PLUS
2
Cleared 510(K)
K
87
2257
TAMPAX PETAL SOFT DEODORANT TAMPON, REGULAR
2
Cleared 510(K)
K
87
1197
PLAYTEX TAMPONS AND DEODORANT TAMPONS
2
Cleared 510(K)
K
86
4498
O.B.(TM) TAMPON
2
Cleared 510(K)
K
86
1738
PLAYTEX TAMPONS
2
Cleared 510(K)
K
86
2353
TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)
2
Cleared 510(K)
K
85
4258
PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA
2
Cleared 510(K)
K
84
3551
PLAYTEX BABY POWDER DEODORANT TAMPONS
2
Cleared 510(K)
K
84
1155
DEODORANT SLENDER REG. TAMPONS
2
Cleared 510(K)
K
84
1154
PLAYTEX SLENDER REGULAR TAMPONS
2
Cleared 510(K)
K
83
0966
PLAYTEX TAMPONS
2
Cleared 510(K)
K
81
2618
ASSURE NATURAL FIT TAMPON
2
Cleared 510(K)
K
81
2534
IMPROVED PLAYTEX TAMPON
2
Cleared 510(K)
K
81
1387
PLAYTEX COMBINATION FIBER MODIFIED TAMP
2
Cleared 510(K)
K
81
1389
PLAYTEX COTTON TAMPONS
2
Cleared 510(K)
K
81
1660
PLAYTEX MODIFIED FIBER TAMPONS
2
Cleared 510(K)
K
81
1386
PLAYTEX PROCESS MACHINERY CHANGE
2
Cleared 510(K)
K
81
1214
ASSURE NATURAL FIT TAMPON
2
Cleared 510(K)
K
81
0143
TAMPAX DEODORANT TAMPONS
2
Cleared 510(K)
K
80
0272
RELY DEODERANT TAMPON
2
Cleared 510(K)
K
79
2627
STERILIZATION PROCESS/MATERNITY PAD
2
Cleared 510(K)
K
78
1085
ASSURE NATURAL FIT TAMPON
2
Cleared 510(K)
K
78
0058
TAMPON, HEAVY DUTY, & STICK
2
Cleared 510(K)
K
77
1012
ASSURE DEODORANT TAMPONS
2
Cleared 510(K)
K
76
1184
RELY TAMPON
2
Cleared 510(K)
K
76
0425
TAMPON, PLAYTEX 2 VERSION A
2
Cleared 510(K)
K
76
0426
TAMPON, PLAYTEX 2 VERSION B
2
Cleared 510(K)
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 31 January 2025 at 11:05 pm
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subpart-f—obstetrical-and-gynecological-therapeutic-devices
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HIL
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K872260
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TAMPAX DEODORANT TAMPON, SLENDER REGULAR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K872260
510(k) Type
Traditional
Applicant
TAMBRANDS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/10/1987
Days to Decision
30 days
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
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
K
13
2208
ONTEX AND OTHERS PROPRIETARY NAMES
K
13
2819
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
K
12
0245
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
K
11
1684
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
K
08
1555
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
K
07
3662
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
K
07
2376
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
K
07
0745
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
K
06
0981
PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
K
05
1446
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
K
05
0067
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
K
04
2773
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
K
04
0312
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
K
03
2173
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
K
03
2080
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
K
02
2882
MODIFICATION TO PLAYTEX TAMPONS #24002
K
02
0200
PLAYTEX DEODORANT TAMPONS, MODEL 34802
K
02
0202
PLAYTEX DEODORANT TAMPONS, MODEL 34702
K
02
0201
PLAYTEX DEODORANT TAMPONS, MODEL 34902
K
01
1996
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
K
01
1171
TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS
K
98
2383
PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS
K
97
1547
PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS
K
96
4269
PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
K
96
1870
PLAYTEX SLIMFIT TAMPONS
K
96
1456
PLAYTEX TAMPONS #10296
K
95
3638
O.B. APPLICATOR TAMPONS
K
95
2344
SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS
K
95
0928
ULTIMATES SILK GLIDE TAMPONS
K
94
1044
PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194
K
94
1196
PLATEX TAMPONS MODEL NUMBER 07094
K
94
0821
PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED
K
93
6189
PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED
K
93
5276
PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS
K
93
4083
PLAYTEX ULTIMATES TAMPONS
K
93
2909
PLAYTEX ULTIMATES TAMPONS
K
93
2907
PLAYTEX ULTIMATES TAMPONS
K
92
2834
TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY
K
92
4279
PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER +
K
91
4438
PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS
K
91
2002
PLAYTEX NON-DEODORANT/DEODORANT TAMPONS
K
90
5378
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS
K
89
7012
SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS
K
89
6115
TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER
K
89
1297
PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS
K
88
4737
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS
K
88
1057
PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER
K
88
0024
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS
K
88
0023
TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON
K
88
0022
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON
K
87
3457
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
K
87
4509
PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL
K
87
2261
TAMPAX DEODORANT TAMPON, SUPER
K
87
2258
TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER PLUS
K
87
2259
TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER
K
87
2260
TAMPAX DEODORANT TAMPON, SLENDER REGULAR
K
87
2256
TAMPAX DEODORANT TAMPON, ORIGINAL REGULAR
K
87
2255
TAMPAX DEODORANT TAMPON, SUPER PLUS
K
87
2257
TAMPAX PETAL SOFT DEODORANT TAMPON, REGULAR
K
87
1197
PLAYTEX TAMPONS AND DEODORANT TAMPONS
K
86
4498
O.B.(TM) TAMPON
K
86
1738
PLAYTEX TAMPONS
K
86
2353
TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)
K
85
4258
PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA
K
84
3551
PLAYTEX BABY POWDER DEODORANT TAMPONS
K
84
1155
DEODORANT SLENDER REG. TAMPONS
K
84
1154
PLAYTEX SLENDER REGULAR TAMPONS
K
83
0966
PLAYTEX TAMPONS
K
81
2618
ASSURE NATURAL FIT TAMPON
K
81
2534
IMPROVED PLAYTEX TAMPON
K
81
1387
PLAYTEX COMBINATION FIBER MODIFIED TAMP
K
81
1389
PLAYTEX COTTON TAMPONS
K
81
1660
PLAYTEX MODIFIED FIBER TAMPONS
K
81
1386
PLAYTEX PROCESS MACHINERY CHANGE
K
81
1214
ASSURE NATURAL FIT TAMPON
K
81
0143
TAMPAX DEODORANT TAMPONS
K
80
0272
RELY DEODERANT TAMPON
K
79
2627
STERILIZATION PROCESS/MATERNITY PAD
K
78
1085
ASSURE NATURAL FIT TAMPON
K
78
0058
TAMPON, HEAVY DUTY, & STICK
K
77
1012
ASSURE DEODORANT TAMPONS
K
76
1184
RELY TAMPON
K
76
0425
TAMPON, PLAYTEX 2 VERSION A
K
76
0426
TAMPON, PLAYTEX 2 VERSION B
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
/
HIL
/
K872260
View Source
TAMPAX DEODORANT TAMPON, SLENDER REGULAR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K872260
510(k) Type
Traditional
Applicant
TAMBRANDS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/10/1987
Days to Decision
30 days