Cleared Traditional

UNSCENTED MENSTRUAL TAMPONS

K851941 · Personal Products Co. · Obstetrics & Gynecology

Aug 1985

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K851941 is an FDA 510(k) clearance for the UNSCENTED MENSTRUAL TAMPONS, 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 August 23, 1985, 112 days after receiving the submission on May 3, 1985. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K851941 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 1985
Decision Date	August 23, 1985
Days to Decision	112 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.