FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS
K Number: K971547
·
Decision Jun 19, 1997
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
83
Applicant Total
17
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS
- K Number
- K971547
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5460
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Playtex Products, Inc.
- Date Received
- April 28, 1997
- Decision Date
- June 19, 1997
- Product Code
- HIL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIL), ordered by most recent decision date.
ONTEX AND OTHERS PROPRIETARY NAMES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Playtex Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K073662 | PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS | Jan 17, 2008 | Substantially Equivalent |
| K072376 | PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS | Dec 12, 2007 | Substantially Equivalent |
| K070745 | MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS | Apr 13, 2007 | Substantially Equivalent |
| K061013 | PLAYTEX EMBRACE PETITE BREAST PUMP | Aug 15, 2006 | Substantially Equivalent |
| K060981 | PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS | May 9, 2006 | Substantially Equivalent |
| K032636 | PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED) | Nov 14, 2003 | Substantially Equivalent |
| K022594 | PLAYTEX BREAST PUMP | Nov 1, 2002 | Substantially Equivalent |
| K022882 | MODIFICATION TO PLAYTEX TAMPONS #24002 | Sep 16, 2002 | Substantially Equivalent |
| K020200 | PLAYTEX DEODORANT TAMPONS, MODEL 34802 | Mar 13, 2002 | Substantially Equivalent |
| K020201 | PLAYTEX DEODORANT TAMPONS, MODEL 34902 | Mar 12, 2002 | Substantially Equivalent |