Cleared Traditional

PLAYTEX SLIMFIT TAMPONS

K961870 · Playtex Products, Inc. · Obstetrics & Gynecology

Jun 1996

Decision

40d

Days

Class 2

Risk

About This 510(k) Submission

K961870 is an FDA 510(k) clearance for the PLAYTEX SLIMFIT TAMPONS, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex Products, Inc. (Paramus, US). The FDA issued a Cleared decision on June 19, 1996, 40 days after receiving the submission on May 10, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K961870 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 1996
Decision Date	June 19, 1996
Days to Decision	40 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.