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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 K101018
Device Name CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
Applicant
CARDICA, INC.
900 SAGINAW DR.
REDWOOD CITY,  CA  94063
Applicant Contact MATTHEW E CHROUST
Correspondent
CARDICA, INC.
900 SAGINAW DR.
REDWOOD CITY,  CA  94063
Correspondent Contact MATTHEW E CHROUST
Regulation Number878.4300
Classification Product Code
FZP  
Date Received04/13/2010
Decision Date 06/25/2010
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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