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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 BK170096
Tradename Fibrinet® Platelet System
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Cascade Medical Enterprises, LLC
20 greenup court
wayne,  NJ  07470
Regulation Number864.9245
Classification Product Code
ORG  
Date Received08/23/2017
Decision Date 11/21/2017
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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