VAS DILATOR— 510(k) K922192

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K922192 for VAS DILATOR, Substantially Equivalent on 1992-08-07. Applicant: Cook Urological, Inc.. Device class: 1.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code KOA
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1992-05-11
Decision date: 1992-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.