PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS— 510(k) K993794

Substantially Equivalent

Playtime Products, Inc.

FDA 510(k) clearance K993794 for PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS, Substantially Equivalent on 2000-02-07. Applicant: Playtime Products, Inc..

Clearance details

Applicant: Playtime Products, Inc.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1999-11-09
Decision date: 2000-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, 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.