Cleared Traditional

UNSCENTED MENSTRUAL TAMPON

K894846 · Personal Products Co. · Obstetrics & Gynecology

Oct 1989

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K894846 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 October 16, 1989, 77 days after receiving the submission on July 31, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K894846 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 1989
Decision Date	October 16, 1989
Days to Decision	77 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.