Cleared Traditional

K840679 - SERENITY CONTOURED ABSORBENT SHIELDS
(FDA 510(k) Clearance)

K840679 · Johnson & Johnson Consumer Products, Inc. · Gastroenterology & Urology

Mar 1984

Decision

36d

Days

Class 1

Risk

K840679 is an FDA 510(k) clearance for the SERENITY CONTOURED ABSORBENT SHIELDS, a Garment, Protective, For Incontinence (Class I — General Controls, product code EYQ), submitted by Johnson & Johnson Consumer Products, Inc. (Skillman, US). The FDA issued a Cleared decision on March 22, 1984, 36 days after receiving the submission on February 15, 1984. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5920.

Submission Details

510(k) Number	K840679 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 1984
Decision Date	March 22, 1984
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—