Cleared Traditional

TAMPAX DEODORANT TAMPON, SUPER

K872261 · Tambrands, Inc. · Obstetrics & Gynecology

Jul 1987

Decision

34d

Days

Class 2

Risk

About This 510(k) Submission

K872261 is an FDA 510(k) clearance for the TAMPAX DEODORANT TAMPON, SUPER, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on July 14, 1987, 34 days after receiving the submission on June 10, 1987. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K872261 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 1987
Decision Date	July 14, 1987
Days to Decision	34 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.