COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES— 510(k) K970764

Name: FDA 510(k) clearance K970764
Creator: U.S. Food and Drug Administration
Published: 1997-04-22

Substantially Equivalent

Comeg Endoscopy

FDA 510(k) clearance K970764 for COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES, Substantially Equivalent on 1997-04-22. Applicant: Comeg Endoscopy. Device class: 2.

Clearance details

Applicant: Comeg Endoscopy
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1997-03-03
Decision date: 1997-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, CO, US

Download summary PDF View on FDA.gov ↗

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