Cleared Traditional

ATTENDS INCONTINENT BRIEF

K873036 · Procter & Gamble Mfg. Co. · Gastroenterology & Urology
Jan 1988
Decision
168d
Days
Class 1
Risk

About This 510(k) Submission

K873036 is an FDA 510(k) clearance for the ATTENDS INCONTINENT BRIEF, a Garment, Protective, For Incontinence (Class I — General Controls, product code EYQ), submitted by Procter & Gamble Mfg. Co. (Cincinnati, US). The FDA issued a Cleared decision on January 19, 1988, 168 days after receiving the submission on August 4, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5920.

Submission Details

510(k) Number K873036 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1987
Decision Date January 19, 1988
Days to Decision 168 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EYQ — Garment, Protective, For Incontinence
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5920

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