Gem FlowCoupler System— 510(k) K190499

Substantially Equivalent

Baxter/ Synovis Micro Companies Alliance, Inc.

FDA 510(k) clearance K190499 for Gem FlowCoupler System, Substantially Equivalent on 2019-09-06. Applicant: Baxter/ Synovis Micro Companies Alliance, Inc..

Clearance details

Applicant: Baxter/ Synovis Micro Companies Alliance, Inc.
Product code: Code MVR
Advisory panel: General, Plastic Surgery
Date received: 2019-03-01
Decision date: 2019-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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