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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 K040832
Device Name C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050
Applicant
CARDICA, INC.
900 SAGINAW DR.
REDWOOD CITY,  CA  94063
Applicant Contact SEVRINA CIUCCI
Correspondent
CARDICA, INC.
900 SAGINAW DR.
REDWOOD CITY,  CA  94063
Correspondent Contact SEVRINA CIUCCI
Regulation Number878.4300
Classification Product Code
FZP  
Date Received03/31/2004
Decision Date 11/10/2005
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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