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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 K132581
Device Name MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE
Applicant
Cardica, Inc.
900 Saginaw Dr.
Redwood City,  CA  94063
Applicant Contact FREDERICK BAUER
Correspondent
Cardica, Inc.
900 Saginaw Dr.
Redwood City,  CA  94063
Correspondent Contact FREDERICK BAUER
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/16/2013
Decision Date 01/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01476761
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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