URINARY DIVERSION EVACUATING CATHETER— 510(k) K914692

Name: FDA 510(k) clearance K914692
Creator: U.S. Food and Drug Administration
Published: 1992-07-02

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K914692 for URINARY DIVERSION EVACUATING CATHETER, Substantially Equivalent on 1992-07-02. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code EXD
Device class: Class 2
Regulation: 21 CFR 876.5895
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-18
Decision date: 1992-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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