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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 K093310
Device Name GEM FLOW COUPLER DEVICE AND SYSTEM
Applicant
Synovis Micro Companies Alliance, Inc.
2575 University Ave.
St. Paul,  MN  55114
Applicant Contact MELISSA J FORTH
Correspondent
Synovis Micro Companies Alliance, Inc.
2575 University Ave.
St. Paul,  MN  55114
Correspondent Contact MELISSA J FORTH
Regulation Number878.4300
Classification Product Code
MVR  
Subsequent Product Code
DPW  
Date Received10/22/2009
Decision Date 02/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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