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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 BK200449
Tradename Healeon Duet
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Haeleon Medical, Inc.
1090 lawrence dr
newbury park,  CA  91320
Regulation Number864.9245
Classification Product Code
ORG  
Date Received01/27/2020
Decision Date 08/06/2020
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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