SURGITEK CO2 DELIVERY SYSTEM— 510(k) K881736

Name: FDA 510(k) clearance K881736
Creator: U.S. Food and Drug Administration
Published: 1988-08-11

Substantially Equivalent

Medical Engineering Corp.

FDA 510(k) clearance K881736 for SURGITEK CO2 DELIVERY SYSTEM, Substantially Equivalent on 1988-08-11. Applicant: Medical Engineering Corp.. Device class: 2.

Clearance details

Applicant: Medical Engineering Corp.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1988-04-22
Decision date: 1988-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, 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.