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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name platelet and plasma separator for bone graft handling
510(k) Number BK150221
Tradename Circle Biologics Autologous Platelet Separator (APS) System
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Celling Biosciences, Inc.
93 red river st.
austin,  TX  78701
Regulation Number864.9245
Classification Product Code
ORG  
Date Received02/03/2015
Decision Date 06/09/2015
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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