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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
Original Applicant
RegenLab SA
3428 avenue marcil
montreal,  Quebec,  H4A 2Z3,  CA
Current 510(k) Holder *
RegenLab SA
en budron b-2
le mont-sur-lausanne,  SWITZERLAND  1052
No 510(k) contact with active listings identified
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
Reviewed by Third Party No
Expedited Review No
Combination Product No
* Based on currently available data in Establishment Registration and Device Listing