GEM FLOW COUPLER DEVICE AND SYSTEM— 510(k) K093310

Name: FDA 510(k) clearance K093310
Creator: U.S. Food and Drug Administration
Published: 2010-02-01

Substantially Equivalent

Synovis Micro Companies Alliance, Inc.

FDA 510(k) clearance K093310 for GEM FLOW COUPLER DEVICE AND SYSTEM, Substantially Equivalent on 2010-02-01. Applicant: Synovis Micro Companies Alliance, Inc.. Device class: 2.

Clearance details

Applicant: Synovis Micro Companies Alliance, Inc.
Product code: Code MVR
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2009-10-22
Decision date: 2010-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, 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.