Cleared Traditional

TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON

K880022 · Tambrands, Inc. · Obstetrics & Gynecology

Mar 1988

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K880022 is an FDA 510(k) clearance for the TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON, 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 March 2, 1988, 57 days after receiving the submission on January 5, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K880022 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 1988
Decision Date	March 02, 1988
Days to Decision	57 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.