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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 BK120066
Tradenames RegenKit-ATS-3, RegenKit-BCT-1 Plus, RegenKit-BCT-2 Plus
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
RegenLab SA
3428 avenue marcil
montreal,  Quebec,  H4A 2Z3,  CANADA
Regulation Number864.9245
Classification Product Code
Date Received11/02/2012
Decision Date 02/05/2014
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