Cleared Traditional

ADULT ABSORBENT INCONTINENT BRIEF

K854408 · Weyerhaeuser Co. · Gastroenterology & Urology
Nov 1985
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K854408 is an FDA 510(k) clearance for the ADULT ABSORBENT INCONTINENT BRIEF, a Garment, Protective, For Incontinence (Class I — General Controls, product code EYQ), submitted by Weyerhaeuser Co. (Tacoma, US). The FDA issued a Cleared decision on November 19, 1985, 18 days after receiving the submission on November 1, 1985. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5920.

Submission Details

510(k) Number K854408 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1985
Decision Date November 19, 1985
Days to Decision 18 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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