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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 BK210563
Tradename Royal Maxx Autologous PRP Concentration System
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Royal Biologics Inc
401 hackensack ave
hackensack,  NJ  07601
Regulation Number864.9245
Classification Product Code
ORG  
Date Received03/17/2021
Decision Date 04/16/2021
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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