Cleared Traditional

TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)

K051290 · Procter & Gamble Co. · Obstetrics & Gynecology

Dec 2005

Decision

223d

Days

Class 2

Risk

About This 510(k) Submission

K051290 is an FDA 510(k) clearance for the TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED), 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 December 27, 2005, 223 days after receiving the submission on May 18, 2005. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K051290 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2005
Decision Date	December 27, 2005
Days to Decision	223 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.