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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 K103313
Device Name HEPARIN ASSAY CONTROLS
Applicant
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Applicant Contact JEFFREY L KOLL
Correspondent
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Correspondent Contact JEFFREY L KOLL
Regulation Number864.5425
Classification Product Code
GGN  
Date Received11/10/2010
Decision Date 12/01/2010
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
Predetermined Change
Control Plan Authorized		 No
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