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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood establishment computer software and accessories
510(k) Number BK090051
Tradename Horizon MobileCare Transfusion
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
McKesson Provider Technologies
5995 windward parkway
alpharetta,  GA  30005
Regulation Number864.9165
Classification Product Code
MMH  
Date Received09/08/2009
Decision Date 05/28/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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