MENSTRUAL TAMPON— 510(k) K953333

Name: FDA 510(k) clearance K953333
Creator: U.S. Food and Drug Administration
Published: 1995-12-06

Substantially Equivalent

Paragon Trade Brands, Inc.

FDA 510(k) clearance K953333 for MENSTRUAL TAMPON, Substantially Equivalent on 1995-12-06. Applicant: Paragon Trade Brands, Inc.. Device class: 2.

Clearance details

Applicant: Paragon Trade Brands, Inc.
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 1995-07-17
Decision date: 1995-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Federal Way, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEB

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K252613 — Unscented menstrual three-piece applicator tampon2025-09-19
K251033 — Unscented menstrual long applicator tampon +3 more2025-08-13

More clearances from Paragon Trade Brands, Inc.

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K983381 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS1998-10-19
K981953 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS1998-08-18
K962953 — DEODORANT PANTY SHIELD1996-10-10
K962954 — DEODORANT MAXI PAD1996-10-10
K962962 — DEODORANT PANTY LINER1996-10-10

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.