Cleared Traditional

DRIPRIDE PROVIDE SLIM

K883894 · Weyerhaeuser Co. · Gastroenterology & Urology
Jan 1989
Decision
138d
Days
Class 1
Risk

About This 510(k) Submission

K883894 is an FDA 510(k) clearance for the DRIPRIDE PROVIDE SLIM, a Garment, Protective, For Incontinence (Class I — General Controls, product code EYQ), submitted by Weyerhaeuser Co. (Washington, US). The FDA issued a Cleared decision on January 30, 1989, 138 days after receiving the submission on September 14, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5920.

Submission Details

510(k) Number K883894 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1988
Decision Date January 30, 1989
Days to Decision 138 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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