Cleared Traditional

K811389 - PLAYTEX COTTON TAMPONS
(FDA 510(k) Clearance)

K811389 · Playtex, Inc. · Obstetrics & Gynecology

Aug 1981

Decision

81d

Days

Class 2

Risk

K811389 is an FDA 510(k) clearance for the PLAYTEX COTTON TAMPONS. This device is classified as 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 FDA review panel. Regulated under 21 CFR 884.5460. 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..

Submission Details

510(k) Number	K811389 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.