Cleared Traditional

TAMPAX DEODORANT TAMPON, SUPER PLUS

K872255 · Tambrands, Inc. · Obstetrics & Gynecology

Jul 1987

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K872255 is an FDA 510(k) clearance for the TAMPAX DEODORANT TAMPON, SUPER PLUS, 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 10, 1987, 30 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	K872255 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 1987
Decision Date	July 10, 1987
Days to Decision	30 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.