GEM Flow COUPLER Device and System— 510(k) K143589

Substantially Equivalent

Synovis Life Technologies, Inc.

FDA 510(k) clearance K143589 for GEM Flow COUPLER Device and System, Substantially Equivalent on 2015-01-16. Applicant: Synovis Life Technologies, Inc..

Clearance details

Applicant: Synovis Life Technologies, Inc.
Product code: Code MVR
Advisory panel: General, Plastic Surgery
Date received: 2014-12-18
Decision date: 2015-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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