Cleared Special

MODIFICATION TO PLAYTEX TAMPONS #24002

K022882 · Playtex Products, Inc. · Obstetrics & Gynecology

Sep 2002

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K022882 is an FDA 510(k) clearance for the MODIFICATION TO PLAYTEX TAMPONS #24002, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex Products, Inc. (Allendale, US). The FDA issued a Cleared decision on September 16, 2002, 17 days after receiving the submission on August 30, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K022882 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2002
Decision Date	September 16, 2002
Days to Decision	17 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.