AQ HYDROPHILIC UROLOGICAL CATHETERS— 510(k) K962004

Name: FDA 510(k) clearance K962004
Creator: U.S. Food and Drug Administration
Published: 1996-06-11

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K962004 for AQ HYDROPHILIC UROLOGICAL CATHETERS, Substantially Equivalent on 1996-06-11. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1996-05-22
Decision date: 1996-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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