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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 K042175
Device Name HEPARINASE HR ACT CONTROL, MODEL 550-12
Applicant
Medtronic Vascular
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact DAWN STENSTROM
Correspondent
Medtronic Vascular
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact DAWN STENSTROM
Regulation Number864.5425
Classification Product Code
GGN  
Subsequent Product Code
JBP  
Date Received08/11/2004
Decision Date 10/18/2004
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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