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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name device, mixing and weighing, semi-automated
510(k) Number BK160095
Tradename MacoMix HM20 and optional Hemolog 6 Software
Device Name Device, Mixing and Weighing, Semi-automated
Original Applicant
MacoProductions S.A.S.
200 chaussee fernand forest
Tourcoing,  59200, 
Regulation Number864.9195
Classification Product Code
MYJ  
Date Received09/30/2016
Decision Date 08/11/2017
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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