Cleared Traditional

TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS

K960341 · Tambrands, Inc. · Obstetrics & Gynecology

Apr 1996

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K960341 is an FDA 510(k) clearance for the TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on April 17, 1996, 84 days after receiving the submission on January 24, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K960341 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 1996
Decision Date	April 17, 1996
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented 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.