Cleared Traditional

MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS

K860598 · Procter & Gamble Mfg. Co. · Gastroenterology & Urology
Mar 1986
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K860598 is an FDA 510(k) clearance for the MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS, 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 March 5, 1986, 14 days after receiving the submission on February 19, 1986. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5920.

Submission Details

510(k) Number K860598 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1986
Decision Date March 05, 1986
Days to Decision 14 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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