Cleared Traditional

PLAYTEX TAMPONS MODEL 13794

K942418 · Playtex, Inc. · Obstetrics & Gynecology

Jul 1994

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K942418 is an FDA 510(k) clearance for the PLAYTEX TAMPONS MODEL 13794, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Playtex, Inc. (Paramus, US). The FDA issued a Cleared decision on July 8, 1994, 49 days after receiving the submission on May 20, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K942418 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 1994
Decision Date	July 08, 1994
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented 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.