FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
K Number: K032636
·
Decision Nov 14, 2003
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
17
Review Days
79
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Basic Information
- Device Name
- PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
- K Number
- K032636
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Playtex Products, Inc.
- Date Received
- August 27, 2003
- Decision Date
- November 14, 2003
- Product Code
- HEB
- 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 |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | FDA class 2 | Obstetrics/Gynecology |
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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 |
| 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 |
| K020202 | PLAYTEX DEODORANT TAMPONS, MODEL 34702 | Mar 12, 2002 | Substantially Equivalent |