PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)— 510(k) K032636
Substantially EquivalentPlaytex Products, Inc.
FDA 510(k) clearance K032636 for PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED), Substantially Equivalent on 2003-11-14. Applicant: Playtex Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Playtex Products, Inc.
- Product code
- Code HEB
- Device class
- Class 2
- Regulation
- 21 CFR 884.5470
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
Recent devices under product code HEB
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- K061013 — PLAYTEX EMBRACE PETITE BREAST PUMP
- K060981 — PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
Adverse events under product code HEB
product code HEB- Injury
- 329
- Malfunction
- 5,647
- Total
- 5,976
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.