Cleared Traditional

PLAYTEX DEODORANT TAMPONS, MODEL 34802

K020200 · Playtex Products, Inc. · Obstetrics & Gynecology

Mar 2002

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K020200 is an FDA 510(k) clearance for the PLAYTEX DEODORANT TAMPONS, MODEL 34802, 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 March 13, 2002, 50 days after receiving the submission on January 22, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K020200 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 2002
Decision Date	March 13, 2002
Days to Decision	50 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.