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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cord blood processing system and storage container
510(k) Number BK140203
Tradename Sepax Cell Separtaton System and SIngle Use Kits
Device Name Cord blood processing system and storage container
Original Applicant
Biosafe SA
route du petit-eysins
eysins,  Vaud,  1262, 
Regulation Number864.9900
Classification Product Code
OAO  
Date Received11/20/2014
Decision Date 02/13/2015
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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