GABRIEL URETERAL ILLUMINATOR SYSTEM II— 510(k) K945088

Name: FDA 510(k) clearance K945088
Creator: U.S. Food and Drug Administration
Published: 1995-02-07

Substantially Equivalent

Gabriel Medical, Inc.

FDA 510(k) clearance K945088 for GABRIEL URETERAL ILLUMINATOR SYSTEM II, Substantially Equivalent on 1995-02-07. Applicant: Gabriel Medical, Inc.. Device class: 2.

Clearance details

Applicant: Gabriel Medical, Inc.
Product code: Code FCS
Device class: Class 2
Regulation: 21 CFR 876.4020
Advisory panel: Gastroenterology, Urology
Date received: 1994-10-17
Decision date: 1995-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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