Cleared Special

TAMPAX M PLASTIC TAMPONS, UNSCENTED

K133244 · The Procter & Gamble Company · Obstetrics & Gynecology

Jan 2014

Decision

79d

Days

Class 2

Risk

About This 510(k) Submission

K133244 is an FDA 510(k) clearance for the TAMPAX M PLASTIC TAMPONS, UNSCENTED, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by The Procter & Gamble Company (Cincinnati, US). The FDA issued a Cleared decision on January 9, 2014, 79 days after receiving the submission on October 22, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K133244 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 22, 2013
Decision Date	January 09, 2014
Days to Decision	79 days
Submission Type	Special
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.