Cleared Traditional

PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER

K881057 · Playtex, Inc. · Obstetrics & Gynecology

Mar 1988

Decision

11d

Days

Class 2

Risk

About This 510(k) Submission

K881057 is an FDA 510(k) clearance for the PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER, 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 March 22, 1988, 11 days after receiving the submission on March 11, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K881057 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 1988
Decision Date	March 22, 1988
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—

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.