Cleared Traditional

K872059 - DRIPRIDE PROVIDE ULTRA
(FDA 510(k) Clearance)

Mar 1988
Decision
293d
Days
Class 1
Risk

K872059 is an FDA 510(k) clearance for the DRIPRIDE PROVIDE ULTRA. This device is classified as 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 March 16, 1988, 293 days after receiving the submission on May 28, 1987.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5920.

Submission Details

510(k) Number K872059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1987
Decision Date March 16, 1988
Days to Decision 293 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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