Cleared Traditional

K040999 - TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
(FDA 510(k) Clearance)

K040999 · Procter & Gamble Co. · Obstetrics & Gynecology

Jul 2004

Decision

81d

Days

Class 2

Risk

K040999 is an FDA 510(k) clearance for the TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES), a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on July 9, 2004, 81 days after receiving the submission on April 19, 2004. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K040999 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2004
Decision Date	July 09, 2004
Days to Decision	81 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.