WILLIAMS PENILE ANESTHETIC RETAINER— 510(k) K896160

Name: FDA 510(k) clearance K896160
Creator: U.S. Food and Drug Administration
Published: 1990-02-16

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K896160 for WILLIAMS PENILE ANESTHETIC RETAINER, Substantially Equivalent on 1990-02-16. Applicant: Cook Urological, Inc.. Device class: 1.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code FHA
Device class: Class 1
Regulation: 21 CFR 876.5160
Advisory panel: Gastroenterology, Urology
Date received: 1989-10-24
Decision date: 1990-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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