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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 K073304
Device Name CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
Applicant
CARDICA, INC.
900 SAGINAW DR.
REDWOOD CITY,  CA  94063
Applicant Contact ISKRA MRAKOVIC
Correspondent
CARDICA, INC.
900 SAGINAW DR.
REDWOOD CITY,  CA  94063
Correspondent Contact ISKRA MRAKOVIC
Regulation Number878.4300
Classification Product Code
FZP  
Date Received11/23/2007
Decision Date 12/20/2007
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
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