Cleared Traditional

DEODORIZING AND SOUND MUFFLING ANAL PAD

K903342 · Biological Resistance, Inc. · Gastroenterology & Urology

Oct 1990

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K903342 is an FDA 510(k) clearance for the DEODORIZING AND SOUND MUFFLING ANAL PAD, a Garment, Protective, For Incontinence (Class I — General Controls, product code EYQ), submitted by Biological Resistance, Inc. (Princeton, US). The FDA issued a Cleared decision on October 23, 1990, 90 days after receiving the submission on July 25, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5920.

Submission Details

510(k) Number	K903342 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 1990
Decision Date	October 23, 1990
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—