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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 BK170136
Tradename Healeon PRP Platelet Preparation System
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Healeon Medical, Inc.
1111 rancho conejo blvd #204
newbury park,  CA  91320
Regulation Number864.9245
Classification Product Code
Date Received10/25/2017
Decision Date 11/20/2018
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