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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K053524
Device Name C-PORT DISTAL ANASTOMOSIS SYSTEM
Applicant
Cardica, Inc.
900 Saginaw Dr.
Redwood City,  CA  94063
Applicant Contact DAVID CASAL
Correspondent
Cardica, Inc.
900 Saginaw Dr.
Redwood City,  CA  94063
Correspondent Contact DAVID CASAL
Regulation Number878.4300
Classification Product Code
FZP  
Date Received12/19/2005
Decision Date 11/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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