Cleared Special

TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED

K081555 · Procter & Gamble Co. · Obstetrics & Gynecology

Jun 2008

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K081555 is an FDA 510(k) clearance for the TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on June 27, 2008, 24 days after receiving the submission on June 3, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K081555 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2008
Decision Date	June 27, 2008
Days to Decision	24 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HIL — Tampon, Menstrual, Scented, Scented-deodorized
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5460
Definition	A Scented Or Scented-deodorized 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.