Cleared Traditional

TAMPAX TAMPON, REGULAR ABSORBENCY

K924303 · Tambrands, Inc. · Obstetrics & Gynecology

Jul 1993

Decision

358d

Days

Class 2

Risk

About This 510(k) Submission

K924303 is an FDA 510(k) clearance for the TAMPAX TAMPON, REGULAR ABSORBENCY, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on July 29, 1993, 358 days after receiving the submission on August 5, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K924303 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 1992
Decision Date	July 29, 1993
Days to Decision	358 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.