Cleared Traditional

TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)

K061486 · Procter & Gamble Co. · Obstetrics & Gynecology

Aug 2006

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K061486 is an FDA 510(k) clearance for the TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES), a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Procter & Gamble Co. (Washington, US). The FDA issued a Cleared decision on August 1, 2006, 62 days after receiving the submission on May 31, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K061486 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2006
Decision Date	August 01, 2006
Days to Decision	62 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.