Cleared Traditional

PLAYTEX COMBINATION FIBER MODIFIED TAMP

K811387 · Playtex, Inc. · Obstetrics & Gynecology

Aug 1981

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K811387 is an FDA 510(k) clearance for the PLAYTEX COMBINATION FIBER MODIFIED TAMP, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1981, 81 days after receiving the submission on May 18, 1981. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K811387 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1981
Decision Date	August 07, 1981
Days to Decision	81 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.