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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 K140170
Device Name MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
Applicant
CARDICA, INC.
900 SAGINAW DR.
REDWOOD CITY,  CA  94063
Applicant Contact VEE ARYA
Correspondent
CARDICA, INC.
900 SAGINAW DR.
REDWOOD CITY,  CA  94063
Correspondent Contact VEE ARYA
Regulation Number878.4750
Classification Product Code
GDW  
Date Received01/23/2014
Decision Date 02/19/2014
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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