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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K161137
Device Name Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
Applicant
CARDICA, INC.
900 Saginaw Dr
Redwood City,  CA  94063
Applicant Contact Greg Watson
Correspondent
CARDICA, INC.
900 Saginaw Dr
Redwood City,  CA  94063
Correspondent Contact Greg Watson
Regulation Number878.4750
Classification Product Code
GDW  
Date Received04/22/2016
Decision Date 07/20/2016
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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