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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., Suite 180
St. Paul,  MN  55114 -1024
Applicant Contact TROY THOME
Correspondent
Synovis Life Technologies, Inc.
2575 University Ave., Suite 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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