Cleared Traditional

MENSTRUAL TAMPON

K897008 · Personal Products Co. · Obstetrics & Gynecology

Jan 1990

Decision

19d

Days

Class 2

Risk

About This 510(k) Submission

K897008 is an FDA 510(k) clearance for the MENSTRUAL TAMPON, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on January 8, 1990, 19 days after receiving the submission on December 20, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K897008 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 1989
Decision Date	January 08, 1990
Days to Decision	19 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.