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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 BK070062
Tradename PROGESA
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
MAK-System
10 avenue de la grande armee
75017 paris,  75017, 
Regulation Number864.9165
Classification Product Code
MMH  
Date Received10/04/2007
Decision Date 10/26/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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