Cleared Traditional

UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR

K912552 · Personal Products Co. · Obstetrics & Gynecology

Sep 1991

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K912552 is an FDA 510(k) clearance for the UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR, 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 September 24, 1991, 105 days after receiving the submission on June 11, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K912552 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 1991
Decision Date	September 24, 1991
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement

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.