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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Heparin, Automated
510(k) Number K102953
Device Name HEPARIN DOSE RESPONSE CARTRIDGE
Applicant
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Applicant Contact JEFFERY L KOLL
Correspondent
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Correspondent Contact JEFFERY L KOLL
Regulation Number864.5680
Classification Product Code
JOX  
Date Received10/04/2010
Decision Date 11/04/2010
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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