PLAYTEX TAMPONS #13695— 510(k) K952394
Substantially EquivalentPlaytime Products, Inc.
FDA 510(k) clearance K952394 for PLAYTEX TAMPONS #13695, Substantially Equivalent on 1995-08-21. Applicant: Playtime Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Playtime 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
- Paramus, NJ, US
Recent devices under product code HEB
view allMore clearances from Playtime Products, Inc.
view all- K993794 — PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
- K981760 — PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
- K964269 — PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
- K961456 — PLAYTEX TAMPONS #10296
- K950928 — ULTIMATES SILK GLIDE 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.