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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 K081225
Device Name CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
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 Received04/30/2008
Decision Date 09/05/2008
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
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