PETAL SOFT PLASTIC APPLICATOR TAMPAX— 510(k) K813642

Name: FDA 510(k) clearance K813642
Creator: U.S. Food and Drug Administration
Published: 1982-01-25

Substantially Equivalent

Tampax, Inc.

FDA 510(k) clearance K813642 for PETAL SOFT PLASTIC APPLICATOR TAMPAX, Substantially Equivalent on 1982-01-25. Applicant: Tampax, Inc.. Device class: 2.

Clearance details

Applicant: Tampax, Inc.
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 1981-12-30
Decision date: 1982-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Tampax, Inc.

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K832971 — DEODORANT MAXITHINS PANTY SHIELD1983-11-28
K832972 — REGULAR DEODORANT MAXITHINS PADS1983-11-28
K832973 — TAMPAX SUPER DEODORANT MAXITHINS1983-11-28
K832974 — MAXITHINS UNSCENTED PANTY SHIELDS1983-10-14
K821800 — REGULAR MAXITHINS PADS & SUPER MAXITHINS1982-06-25

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.