Cleared Traditional

TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS

K040312 · Procter & Gamble Co. · Obstetrics & Gynecology

May 2004

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K040312 is an FDA 510(k) clearance for the TAMPAX PEARL SCENTED TAMPONS-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 May 3, 2004, 84 days after receiving the submission on February 9, 2004. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K040312 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 2004
Decision Date	May 03, 2004
Days to Decision	84 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.