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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 BK230986
Tradename ePROGESA
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
MAK-SYSTEM Group Ltd.
1 bartholomew lane
London,  EC2N 2AX, 
Regulation Number864.9165
Classification Product Code
MMH  
Date Received08/14/2023
Decision Date 11/03/2023
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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