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

Name: FDA 510(k) clearance K993794
Creator: U.S. Food and Drug Administration
Published: 2000-02-07

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.. 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: 1999-11-09
Decision date: 2000-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Playtime Products, Inc.

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K981760 — PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #135981998-07-22
K964269 — PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS1996-11-29
K961456 — PLAYTEX TAMPONS #102961996-06-18
K952394 — PLAYTEX TAMPONS #136951995-08-21
K950928 — ULTIMATES SILK GLIDE TAMPONS1995-03-22

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.