Cleared Traditional

TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS

K011171 · Procter & Gamble Co. · Obstetrics & Gynecology

Jul 2001

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K011171 is an FDA 510(k) clearance for the TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS, 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 July 2, 2001, 76 days after receiving the submission on April 17, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K011171 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2001
Decision Date	July 02, 2001
Days to Decision	76 days
Submission Type	Traditional
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.