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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plasma, coagulation control
510(k) Number K103314
Device Name CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
Applicant
MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact JEFFREY L KOLL
Correspondent
MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact JEFFREY L KOLL
Regulation Number864.5425
Classification Product Code
GGN  
Date Received11/10/2010
Decision Date 12/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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