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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 BK100014
Tradenames Autologous Fluid Concentrator (AFC) System, Changed with 6/25/10 Submission to: "Autologous Platelet Concentrator (APC)(TM) System
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Circle Biologics, Inc.
3650 annapolis lane, suite 105
minneapolis,  MN  55447
Regulation Number864.9245
Classification Product Code
ORG  
Date Received03/01/2010
Decision Date 07/09/2010
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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