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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 K132727
Device Name GEM FLOW COUPLER DEVICE AND SYSTEM
Applicant
SYNOVIS LIFE TECHNOLOGIES, INC.
2575 UNIVERSITY AVE., STE.180
ST. PAUL,  MN  55114 -1024
Applicant Contact TROY THOME
Correspondent
SYNOVIS LIFE TECHNOLOGIES, INC.
2575 UNIVERSITY AVE., STE.180
ST. PAUL,  MN  55114 -1024
Correspondent Contact TROY THOME
Regulation Number878.4300
Classification Product Code
MVR  
Subsequent Product Code
DPW  
Date Received09/03/2013
Decision Date 10/22/2013
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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