PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598— 510(k) K981760

Substantially Equivalent

Playtime Products, Inc.

FDA 510(k) clearance K981760 for PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598, Substantially Equivalent on 1998-07-22. Applicant: Playtime Products, Inc..

Clearance details

Applicant: Playtime Products, Inc.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1998-05-19
Decision date: 1998-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

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Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.