Cleared Traditional

O.B. TAMPON

K941863 · Personal Products Co. · Obstetrics & Gynecology

Jun 1994

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K941863 is an FDA 510(k) clearance for the O.B. 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 June 27, 1994, 73 days after receiving the submission on April 15, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K941863 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 1994
Decision Date	June 27, 1994
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

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.