Cleared Traditional

TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA

K091281 · Procter & Gamble Co. · Obstetrics & Gynecology

Jun 2010

Decision

396d

Days

Class 2

Risk

About This 510(k) Submission

K091281 is an FDA 510(k) clearance for the TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA, 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 June 1, 2010, 396 days after receiving the submission on May 1, 2009. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K091281 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2009
Decision Date	June 01, 2010
Days to Decision	396 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.