UNSCENTED MENSTRUAL TAMPONS— 510(k) K944834

Name: FDA 510(k) clearance K944834
Creator: U.S. Food and Drug Administration
Published: 1994-12-21

Substantially Equivalent

Tambrands, Inc.

FDA 510(k) clearance K944834 for UNSCENTED MENSTRUAL TAMPONS, Substantially Equivalent on 1994-12-21. Applicant: Tambrands, Inc.. Device class: 2.

Clearance details

Applicant: Tambrands, Inc.
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 1994-09-30
Decision date: 1994-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plains, NY, US

Download summary PDF View on FDA.gov ↗

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K962476 — UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR1996-08-13
K960341 — TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS1996-04-17
K952344 — SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS1995-07-28
K923932 — TAMPAX TAMPONS, SUPER ABSORBENCY1993-07-29
K924303 — TAMPAX TAMPON, REGULAR ABSORBENCY1993-07-29

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.