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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number BK090048
Tradename RegenKit-THT
Device Name Syringe, piston
Original Applicant
RegenLab SA
3428 avenue marcil
montreal,  Quebec,  H4A 2Z3, 
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/28/2009
Decision Date 05/18/2010
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
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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