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
- 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
- K132208ONTEX AND OTHERS PROPRIETARY NAMES2Cleared 510(K)
- K132819PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS2Cleared 510(K)
- K120245PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS2Cleared 510(K)
- K111684PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD2Cleared 510(K)
- K081555TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED2Cleared 510(K)
- K073662PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS2Cleared 510(K)
- K072376PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS2Cleared 510(K)
- K070745MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS2Cleared 510(K)
- K060981PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS2Cleared 510(K)
- K051446FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K050067FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K042773ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K040312TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS2Cleared 510(K)
- K032173FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K032080ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS2Cleared 510(K)
- K022882MODIFICATION TO PLAYTEX TAMPONS #240022Cleared 510(K)
- K020200PLAYTEX DEODORANT TAMPONS, MODEL 348022Cleared 510(K)
- K020202PLAYTEX DEODORANT TAMPONS, MODEL 347022Cleared 510(K)
- K020201PLAYTEX DEODORANT TAMPONS, MODEL 349022Cleared 510(K)
- K011996TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS2Cleared 510(K)
- K011171TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS2Cleared 510(K)
- K982383PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS2Cleared 510(K)
- K971547PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS2Cleared 510(K)
- K964269PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS2Cleared 510(K)
- K961870PLAYTEX SLIMFIT TAMPONS2Cleared 510(K)
- K961456PLAYTEX TAMPONS #102962Cleared 510(K)
- K953638O.B. APPLICATOR TAMPONS2Cleared 510(K)
- K952344SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS2Cleared 510(K)
- K950928ULTIMATES SILK GLIDE TAMPONS2Cleared 510(K)
- K941044PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 061942Cleared 510(K)
- K941196PLATEX TAMPONS MODEL NUMBER 070942Cleared 510(K)
- K940821PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED2Cleared 510(K)
- K936189PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED2Cleared 510(K)
- K935276PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS2Cleared 510(K)
- K934083PLAYTEX ULTIMATES TAMPONS2Cleared 510(K)
- K932909PLAYTEX ULTIMATES TAMPONS2Cleared 510(K)
- K932907PLAYTEX ULTIMATES TAMPONS2Cleared 510(K)
- K922834TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY2Cleared 510(K)
- K924279PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER +2Cleared 510(K)
- K914438PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS2Cleared 510(K)
- K912002PLAYTEX NON-DEODORANT/DEODORANT TAMPONS2Cleared 510(K)
- K905378PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS2Cleared 510(K)
- K897012SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS2Cleared 510(K)
- K896115TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER2Cleared 510(K)
- K891297PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS2Cleared 510(K)
- K884737PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS2Cleared 510(K)
- K881057PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER2Cleared 510(K)
- K880024TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS2Cleared 510(K)
- K880023TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON2Cleared 510(K)
- K880022TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON2Cleared 510(K)
- K873457SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS2Cleared 510(K)
- K874509PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL2Cleared 510(K)
- K872261TAMPAX DEODORANT TAMPON, SUPER2Cleared 510(K)
- K872260TAMPAX DEODORANT TAMPON, SLENDER REGULAR2Cleared 510(K)
- K872255TAMPAX DEODORANT TAMPON, SUPER PLUS2Cleared 510(K)
- K872257TAMPAX PETAL SOFT DEODORANT TAMPON, REGULAR2Cleared 510(K)
- K872256TAMPAX DEODORANT TAMPON, ORIGINAL REGULAR2Cleared 510(K)
- K872258TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER PLUS2Cleared 510(K)
- K872259TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER2Cleared 510(K)
- K871197PLAYTEX TAMPONS AND DEODORANT TAMPONS2Cleared 510(K)
- K864498O.B.(TM) TAMPON2Cleared 510(K)
- K861738PLAYTEX TAMPONS2Cleared 510(K)
- K862353TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)2Cleared 510(K)
- K854258PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA2Cleared 510(K)
- K843551PLAYTEX BABY POWDER DEODORANT TAMPONS2Cleared 510(K)
- K841155DEODORANT SLENDER REG. TAMPONS2Cleared 510(K)
- K841154PLAYTEX SLENDER REGULAR TAMPONS2Cleared 510(K)
- K830966PLAYTEX TAMPONS2Cleared 510(K)
- K812618ASSURE NATURAL FIT TAMPON2Cleared 510(K)
- K812534IMPROVED PLAYTEX TAMPON2Cleared 510(K)
- K811387PLAYTEX COMBINATION FIBER MODIFIED TAMP2Cleared 510(K)
- K811389PLAYTEX COTTON TAMPONS2Cleared 510(K)
- K811660PLAYTEX MODIFIED FIBER TAMPONS2Cleared 510(K)
- K811386PLAYTEX PROCESS MACHINERY CHANGE2Cleared 510(K)
- K811214ASSURE NATURAL FIT TAMPON2Cleared 510(K)
- K810143TAMPAX DEODORANT TAMPONS2Cleared 510(K)
- K800272RELY DEODERANT TAMPON2Cleared 510(K)
- K792627STERILIZATION PROCESS/MATERNITY PAD2Cleared 510(K)
- K781085ASSURE NATURAL FIT TAMPON2Cleared 510(K)
- K780058TAMPON, HEAVY DUTY, & STICK2Cleared 510(K)
- K771012ASSURE DEODORANT TAMPONS2Cleared 510(K)
- K761184RELY TAMPON2Cleared 510(K)
- K760425TAMPON, PLAYTEX 2 VERSION A2Cleared 510(K)
- K760426TAMPON, PLAYTEX 2 VERSION B2Cleared 510(K)
- 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
PLAYTEX PROCESS MACHINERY CHANGE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K811386
- 510(k) Type
- Traditional
- Applicant
- PLAYTEX, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/10/1981
- Days to Decision
- 53 days