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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anastomotic, Microvascular
510(k) Number K143589
Device Name GEM Flow COUPLER Device and System
Applicant
Synovis Life Technologies, Inc.
2575 University Ave. West, Suite 180
St. Paul,  MN  55114
Applicant Contact Jodi Jorgenson
Correspondent
Synovis Life Technologies, Inc.
2575 University Ave. West, Suite 180
St. Paul,  MN  55114
Correspondent Contact Jodi Jorgenson
Regulation Number878.4300
Classification Product Code
MVR  
Subsequent Product Code
DPW  
Date Received12/18/2014
Decision Date 01/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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