Cleared Traditional

UNSCENTED MENSTRUAL TAMPON

K897007 · Personal Products Co. · Obstetrics & Gynecology

Jul 1990

Decision

207d

Days

Class 2

Risk

About This 510(k) Submission

K897007 is an FDA 510(k) clearance for the UNSCENTED 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 July 13, 1990, 207 days after receiving the submission on December 18, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K897007 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 1989
Decision Date	July 13, 1990
Days to Decision	207 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.