510(k) K020202
- Device
- PLAYTEX DEODORANT TAMPONS, MODEL 34702
- Applicant
- PLAYTEX PRODUCTS, INC.
- 510(k) number
- K020202
- Product code
- HIL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-03-12
- Date received
- 2002-01-22
- Regulation
- 884.5460
- Classification name
- Tampon, Menstrual, Scented, Deodorized
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK ROSENGARTEN
- Address
- 75 Commerce Dr. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 3021389492
- 3008925277
- 1523399
- 1219109
- 3013445151
- 3004443383
- 3019735068
- 3012118920
- 3004069780
- 3014829931
- 3013354376
- 3012097557
- 3017195494
- 3042370478
- 2515444
- 3012133441
- 3011964664
- 3015271338
- 2938651
- 3012117640
- 3004270595
- 3003896222
- 3026612204
- 3006015326
- 9613295
- 3017125080
- 3014833751
Source Documents#
Other 510(k) Records For Product Code HIL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132208 | ONTEX AND OTHERS PROPRIETARY NAMES | Ontex Bvba | 2014-04-10 |
| K132819 | PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS | Playtex Manufacturing, Inc. | 2013-10-09 |
| K120245 | PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS | Playtex, Inc. | 2012-06-21 |
| K111684 | PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD | Playtex Manufacturing, Inc. | 2012-02-03 |
| K081555 | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED | Procter & Gamble Co. | 2008-06-27 |
| K073662 | PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS | Playtex Products, Inc. | 2008-01-17 |
| K072376 | PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS | Playtex Products, Inc. | 2007-12-12 |
| K070745 | MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS | Playtex Products, Inc. | 2007-04-13 |
| K060981 | PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS | Playtex Products, Inc. | 2006-05-09 |
| K051446 | FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS | First Quality Hygienic, Inc. | 2005-07-14 |
| K050067 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | First Quality Hygienic, Inc. | 2005-02-01 |
| K042773 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2004-11-23 |
| K040312 | TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS | Procter & Gamble Co. | 2004-05-03 |
| K032173 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | First Quality Hygienic, Inc. | 2003-09-03 |
| K032080 | ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2003-08-14 |
Legacy Summary#
summary
FDA Review#
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