GME ExSys 308— 510(k) K150752

Name: FDA 510(k) clearance K150752
Creator: U.S. Food and Drug Administration
Published: 2015-07-31

Substantially Equivalent

Gme (German Medical Engineering) GmbH

FDA 510(k) clearance K150752 for GME ExSys 308, Substantially Equivalent on 2015-07-31. Applicant: Gme (German Medical Engineering) GmbH. Device class: 2.

Clearance details

Applicant: Gme (German Medical Engineering) GmbH
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2015-03-23
Decision date: 2015-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nuerenberg, Bavaria, DE

Download summary PDF View on FDA.gov ↗

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