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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 K043080
Device Name HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
Applicant
Medtronic Vascular
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact BRUCE BACKLUND
Correspondent
Medtronic Vascular
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact BRUCE BACKLUND
Regulation Number864.5680
Classification Product Code
JOX  
Subsequent Product Code
GGC  
Date Received11/08/2004
Decision Date 12/03/2004
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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