Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- HDOValve, Tubal Occlusion3Product Code
- HDRCap, Cervical2Product Code
- HDTDevice, Intrauterine, Contraceptive And Introducer3Product Code
- HDWDiaphragm, Contraceptive (And Accessories)2Product Code
- HEBTampon, Menstrual, Unscented2Product Code
- K240708Organic Cotton Tampon; Organic Cotton PESCVcord Tampon2Cleared 510(K)
- K232060TOSAMA Reusable Applicator2Cleared 510(K)
- K232598Unscented Menstrual Tampon2Cleared 510(K)
- K223883Daye Tampon2Cleared 510(K)
- K231341Organic cotton tampon, Viscose tampon2Cleared 510(K)
- K230419Sequel Tampon with Plastic Applicator2Cleared 510(K)
- K223749U by Kotex® Click® Unscented Menstrual Tampons2Cleared 510(K)
- K222046Unscented Menstrual Tampon2Cleared 510(K)
- K212277Tempo Tampon2Cleared 510(K)
- K220238Cohitech Cottonlock Tampons with Reusable Applicator2Cleared 510(K)
- K211775Cohitech Organic Cotton Non-Applicator Cottonlock Tampons2Cleared 510(K)
- K212479Cohitech Reusable Tampon Applicator2Cleared 510(K)
- K212272Tempo Natural Tampon2Cleared 510(K)
- K212304Callaly Tampliner (super plus absorbency)2Cleared 510(K)
- K211519Every Cycle Reusable Tampon Applicator2Cleared 510(K)
- K211469Callaly Tampliner2Cleared 510(K)
- K201003Callaly Tampliner2Cleared 510(K)
- K192557Youjia Unscented Tampon with Plastic Applicators2Cleared 510(K)
- K191666Unscented W long plastic and cardboard applicator tampons2Cleared 510(K)
- K191431Interlude Rolled Tampons in Plastic Applicator2Cleared 510(K)
- K182142FEMME Applicator Tampon2Cleared 510(K)
- K182817CottonDay Tampon2Cleared 510(K)
- K182814Rael Tampon2Cleared 510(K)
- K190218Unscented Menstrual Tampon2Cleared 510(K)
- K182813COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT2Cleared 510(K)
- K181911Interlude 100% Cotton Tampon2Cleared 510(K)
- K180850re.t.a Reuseable Tampon Applicator2Cleared 510(K)
- K173225Interlude and private label Unscented 3-piece compact applicator tampon2Cleared 510(K)
- K180167Playtex Stella Tampons2Cleared 510(K)
- K172504Tosama Biobased Applicator Tube Menstrual Tampon2Cleared 510(K)
- K172118U by Kotex Click Unscented Menstrual Tampons2Cleared 510(K)
- K162746Ontex and other proprietary names2Cleared 510(K)
- K161877Opal 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 Pl2Cleared 510(K)
- K152284COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS2Cleared 510(K)
- K151470Opal 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 Absorbency2Cleared 510(K)
- K151170Tosama 100% Organic Cotton Menstrual Tampon2Cleared 510(K)
- K142786Ontex Unscented Tampons with Colored Plastic Applicators2Cleared 510(K)
- K150897Tosama 100% Cotton Menstrual Tampon2Cleared 510(K)
- K140077ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED2Cleared 510(K)
- K141294U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS2Cleared 510(K)
- K132595ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS2Cleared 510(K)
- K133244TAMPAX M PLASTIC TAMPONS, UNSCENTED2Cleared 510(K)
- K131543TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED2Cleared 510(K)
- K130609VEEDA 100% COTTON MENSTRUAL TAMPON2Cleared 510(K)
- K122603ONTEX AND OTHER PROPRIETARY NAMES2Cleared 510(K)
- K120481LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,2Cleared 510(K)
- K113699TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED2Cleared 510(K)
- K113036U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS2Cleared 510(K)
- K112635U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS2Cleared 510(K)
- K110669TAMPAX C PLASTIC TAMPONS, UNSCENTED2Cleared 510(K)
- K103311U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS2Cleared 510(K)
- K102445ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K091281TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA2Cleared 510(K)
- K091749U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS2Cleared 510(K)
- K090819ONTEX TAMPON (UNSCENTED)2Cleared 510(K)
- K092054MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON2Cleared 510(K)
- K090071ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K091084MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS2Cleared 510(K)
- K080733COTTONS 100% NATURAL COTTON TAMPONS2Cleared 510(K)
- K090098MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON2Cleared 510(K)
- K080775MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS2Cleared 510(K)
- K062001ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K062638TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS2Cleared 510(K)
- K061486TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)2Cleared 510(K)
- K051290TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)2Cleared 510(K)
- K050660FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K040999TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)2Cleared 510(K)
- K030474PH BUFFERING PLASTIC APPLICATOR TAMPON2Cleared 510(K)
- K032636PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)2Cleared 510(K)
- K031067FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS2Cleared 510(K)
- K023789O.B. TAMPONS2Cleared 510(K)
- K023479FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES2Cleared 510(K)
- K020535INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K992493VIPON TAMPON2Cleared 510(K)
- K002096TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR2Cleared 510(K)
- K001641TAMPONS2Cleared 510(K)
- K993794PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS2Cleared 510(K)
- K990536O.B. TAMPON2Cleared 510(K)
- K991118O.B. APPLICATOR TAMPONS, O.B. TAMPONS2Cleared 510(K)
- K983478ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON2Cleared 510(K)
- K983381VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS2Cleared 510(K)
- K981953VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS2Cleared 510(K)
- K981760PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #135982Cleared 510(K)
- K980478PLAYTEX TAMPONS #034982Cleared 510(K)
- K974629O.B. APPLICATOR AND NON-APPLICATOR TAMPONS2Cleared 510(K)
- K970954O.B. APPLICATOR TAMPONS2Cleared 510(K)
- K971174PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS2Cleared 510(K)
- K971228FEMTEX 100% COTTON TAMPONS2Cleared 510(K)
- K970108HARMONIES MENSTRUAL TAMPON2Cleared 510(K)
- K970232FEMTEX 100% COTTON DENTLE TOUCH TAMPONS2Cleared 510(K)
- K965064ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON2Cleared 510(K)
- K963034FEMTEX GENTLE TOUCH TAMPONS2Cleared 510(K)
- K963032FREE CHOICE2Cleared 510(K)
- K962712YSANPOINT) (MENSTRUAL) DIGITAL TAMPON2Cleared 510(K)
- K962476UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR2Cleared 510(K)
- K961926SANPOINT MENSTRUAL TAMPON2Cleared 510(K)
- K960341TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS2Cleared 510(K)
- K954445NON APPLICATOR TAMPON, UNTREATED2Cleared 510(K)
- K954942NATRACAREN APPLICATOR TAMPON2Cleared 510(K)
- K953333MENSTRUAL TAMPON2Cleared 510(K)
- K950194TAMPON, UNTREATED2Cleared 510(K)
- K952394PLAYTEX TAMPONS #136952Cleared 510(K)
- K951924ORGANIC TAMPONS2Cleared 510(K)
- K944064PLAYTEX ULTIMATES SILK GLIDE TAMPONS #228942Cleared 510(K)
- K944155PLAYTEX ULTIMATES SILK GLIDE TAMPONS #230942Cleared 510(K)
- K944154PLAYTEX ULTIMATES SILK GLIDE TAMPONS #229942Cleared 510(K)
- K944834UNSCENTED MENSTRUAL TAMPONS2Cleared 510(K)
- K941936UNSCENTED MENSTRUAL TAMPON2Cleared 510(K)
- K942418PLAYTEX TAMPONS MODEL 137942Cleared 510(K)
- K941863O.B. TAMPON2Cleared 510(K)
- K930400TERRA FEMME2Cleared 510(K)
- K930149KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+2Cleared 510(K)
- K914430NATRACARE TAMPON2Cleared 510(K)
- K920238PRIVATE LABELS AND FEMTEX2Cleared 510(K)
- K924303TAMPAX TAMPON, REGULAR ABSORBENCY2Cleared 510(K)
- K923932TAMPAX TAMPONS, SUPER ABSORBENCY2Cleared 510(K)
- K923985UNSCENTED MENSTRUAL TAMPON2Cleared 510(K)
- K912941TAMPON, UNTREATED2Cleared 510(K)
- K912552UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR2Cleared 510(K)
- K904937PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS2Cleared 510(K)
- K897007UNSCENTED MENSTRUAL TAMPON2Cleared 510(K)
- K897008MENSTRUAL TAMPON2Cleared 510(K)
- K896989TAMPAX TAMPON2Cleared 510(K)
- K896994KOTEX SECURITY TAMPONS (SEVERAL TYPE)2Cleared 510(K)
- K896114TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB.2Cleared 510(K)
- K896112TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS2Cleared 510(K)
- K896113TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS2Cleared 510(K)
- K894846UNSCENTED MENSTRUAL TAMPON2Cleared 510(K)
- K893725PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT2Cleared 510(K)
- K885194KOTEX SECURITY TUBE TAMPONS2Cleared 510(K)
- K881384INTERLABIAL PAD2Cleared 510(K)
- K884305KOTEX STICK TAMPONS, REGULAR AND SUPER2Cleared 510(K)
- K883867CERVICAL BIOPSY INSTRUMENT2Cleared 510(K)
- K871715ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONS2Cleared 510(K)
- K872018KOTEX STICK TAMPONS, REGULAR AND SUPER2Cleared 510(K)
- K871642TAMPAX TAMPON, REGULAR2Cleared 510(K)
- K870539O.B. SLENDER REGULAR TAMPON2Cleared 510(K)
- K864859SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS2Cleared 510(K)
- K864652SUPER PLUS TAMPONS2Cleared 510(K)
- K864651SUPER TAMPONS2Cleared 510(K)
- K864650SLENDER REGULAR TAMPONS2Cleared 510(K)
- K864649REGULAR PETAL SOFT PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K864648SUPER PLUS PETAL SOFT PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K870359TAMPAX CLOSED-END FLUSHABLE TAMPON, ORIG. REGULAR2Cleared 510(K)
- K870360TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER PLUS2Cleared 510(K)
- K870361TAMPAX CLOSED-END FLUSHABLE TAMPON, SLENDER REGU.2Cleared 510(K)
- K870358TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER2Cleared 510(K)
- K864750KOTEX SECURITY TAMPONS, REGULAR AND SUPER2Cleared 510(K)
- K863464TAMPAX SUPER TAMPONS2Cleared 510(K)
- K861913SLENDER REGULAR TAMPAX TAMPONS2Cleared 510(K)
- K861912SUPER PLUS TAMPAX TAMPONS2Cleared 510(K)
- K861911SUPER PLUS PETAL SOFT PLASTIC APPLI. TAMPAX TAMPON2Cleared 510(K)
- K861910SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS2Cleared 510(K)
- K861909REGULAR PETAL SOFT PLASTIC APPLI. TAMPAX TAMPONS2Cleared 510(K)
- K861908TAMPAX ORIGINAL REGULAR TAMPON2Cleared 510(K)
- K861907TAMPAX SUPER TAMPONS2Cleared 510(K)
- K861906TAMPAX JUNIOR TAMPONS2Cleared 510(K)
- K853192KOTEX SECURITY TUBE TAMPON2Cleared 510(K)
- K851941UNSCENTED MENSTRUAL TAMPONS2Cleared 510(K)
- K852063PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS2Cleared 510(K)
- K851356PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS2Cleared 510(K)
- K851355PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS2Cleared 510(K)
- K844936SUPER TAMPAX TAMPONS2Cleared 510(K)
- K844935ORIGINAL REGULAR TAMPAX TAMPONS2Cleared 510(K)
- K842619REGULAR PETAL SOFT PLASTIC APPLICATOR2Cleared 510(K)
- K842618SUPER PETAL SOFT PLASTIC APPLICATOR TAMP2Cleared 510(K)
- K832818UNSCENTED MENSTRUAL TAMPON2Cleared 510(K)
- K833179O.B. TAMPONS2Cleared 510(K)
- K820174TAMPAX TAMPONS2Cleared 510(K)
- K813642PETAL SOFT PLASTIC APPLICATOR TAMPAX2Cleared 510(K)
- K812870IMPROVED PLAYTEX TAMPON2Cleared 510(K)
- K811385PLAYTEX DIGITAL TAMPON2Cleared 510(K)
- K811388PLAYTEX COTTON DIGITAL TAMPON2Cleared 510(K)
- K811992ASSURE NATURAL FIT TAMPON2Cleared 510(K)
- K811983JOHNSON & JOHNSON O.B. TAMPONS2Cleared 510(K)
- K802760PETAL SOFT PLASTIC APPLICATOR TAMPAX2Cleared 510(K)
- K802193KOTEX SECURITY TUBE TAMPONS2Cleared 510(K)
- K800777TAMPAX TAMPONS2Cleared 510(K)
- K791274RELY TAMPON2Cleared 510(K)
- K790385KOTEX TUBE AND STICK TAMPON2Cleared 510(K)
- K780648MODIFIED UNTREATED TAMPAX TAMPONS2Cleared 510(K)
- K780243TAMPON, RELY MODIFIED2Cleared 510(K)
- HECInsufflator, Vaginal1Product Code
- HEDDouche Apparatus, Vaginal, Therapeutic1Product Code
- HEESet, Anesthesia, Paracervical2Product Code
- HEGSet, Anesthesia, Pudendal2Product Code
- HEHChamber, Decompression, Abdominal3Product Code
- HFYBand, Tubal Occlusion3Product Code
- HGBClip, Tubal Occlusion3Product Code
- HGFSource, Abortion Unit, Vacuum2Product Code
- HGGController, Abortion Unit, Vacuum2Product Code
- HGHCannula, Suction, Uterine2Product Code
- HGXPump, Breast, Powered2Product Code
- HGYPump, Breast, Non-Powered1Product Code
- HGZHeater, Perineal, Direct Contact2Product Code
- HHAHeater, Perineal, Radiant, Non-Contact2Product Code
- HHDPad, Menstrual, Unscented1Product Code
- HHECup, Menstrual2Product Code
- HHISystem, Abortion, Vacuum2Product Code
- HHLPad, Menstrual, Scented2Product Code
- HHQSystem, Abortion, Metreurynter-Balloon3Product Code
- HHSTranscervical Contraceptive Tubal Occlusion Device3Product Code
- HIIStimulator, Vaginal, Muscle, Powered, For Therapeutic Use3Product Code
- HILTampon, Menstrual, Scented, Deodorized2Product Code
- HISCondom2Product Code
- KNDHeater, Perineal2Product Code
- KNESet, Anesthesia, Obstetric2Product Code
- KNHLaparoscopic Contraceptive Tubal Occlusion Device3Product Code
- KXQVibrator For Therapeutic Use, Genital2Product Code
- LTZCondom With Nonoxynol-92Product Code
- LZLMicro-Condom3Product Code
- MBUSingle-Use Internal Condom2Product Code
- MFDCannula, Intrauterine Insemination2Product Code
- NURPad, Interlabial1Product Code
- MOLCondom, Synthetic2Product Code
- MSCBarrier, Std, Oral Sex2Product Code
- NBVDevice, Engorgement, Clitoral2Product Code
- NRCPads, Menstrual, Scented-Deodorized1Product Code
- NUCLubricant, Personal2Product Code
- NUQPad, Menstrual, Reusable1Product Code
- OBBKit, Conception-Assist, Home Use2Product Code
- OBYCondom, Female, Animal Tissue3Product Code
- PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible2Product Code
- OHHBreast Pump Kit2Product Code
- OKWSeminal Fluid Collection Kit2Product Code
- OOAHemorrhoid Prevention Pressure Wedge2Product Code
- OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed3Product Code
- PAIMesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed3Product Code
- PNUPressure Wedge, Perianal, For Reduction Of Cesarean Delivery2Product Code
- PVTMaternity Kit1Product Code
- PVUObstetrical Anesthesia Kit2Product Code
- PVVParacervical Anesthesia Kit2Product Code
- PVWPudendal Anesthesia Kit2Product Code
- PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pressure1Product Code
- PYTDevice, Fertility Diagnostic, Contraceptive, Software Application2Product Code
- QPDPersonal Lubricant Ring2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
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
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K151470
- 510(k) Type
- Abbreviated
- Applicant
- FIRST QUALITY HYGIENIC, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/2/2015
- Days to Decision
- 154 days
- Submission Type
- Summary