Cleared Traditional

TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS

K896112 · Tambrands, Inc. · Obstetrics & Gynecology

Dec 1989

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K896112 is an FDA 510(k) clearance for the TAMPAX TAMPON, FLUSHABLE APPLICATOR, 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 December 13, 1989, 51 days after receiving the submission on October 23, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K896112 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 1989
Decision Date	December 13, 1989
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—

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.