Cleared Traditional

K830966 - PLAYTEX TAMPONS
(FDA 510(k) Clearance)

K830966 · Playtex, Inc. · Obstetrics & Gynecology

Apr 1983

Decision

11d

Days

Class 2

Risk

K830966 is an FDA 510(k) clearance for the PLAYTEX 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 April 8, 1983, 11 days after receiving the submission on March 28, 1983.

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	K830966 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 1983
Decision Date	April 08, 1983
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.