Cleared Traditional

K841155 - DEODORANT SLENDER REG. TAMPONS
(FDA 510(k) Clearance)

K841155 · Playtex, Inc. · Obstetrics & Gynecology

Mar 1984

Decision

—

Days

Class 2

Risk

K841155 is an FDA 510(k) clearance for the DEODORANT SLENDER REG. TAMPONS. This device is classified as a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL).

Submitted by Playtex, Inc. (Walker, US). The FDA issued a Cleared decision on March 19, 1984.

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	K841155 FDA.gov
FDA Decision	Cleared SESP
Date Received	March 19, 1984
Decision Date	March 19, 1984
Days to Decision	—
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.