Cleared Traditional

PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194

K941044 · Playtex, Inc. · Obstetrics & Gynecology

Jul 1994

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K941044 is an FDA 510(k) clearance for the PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex, Inc. (Paramus, US). The FDA issued a Cleared decision on July 27, 1994, 142 days after receiving the submission on March 7, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K941044 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 1994
Decision Date	July 27, 1994
Days to Decision	142 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.