Device Classification Name |
platelet and plasma separator for bone graft handling
|
510(k) Number |
BK200449 |
Tradename |
Healeon Duet
|
Device Name |
Platelet And Plasma Separator For Bone Graft Handling |
Original Applicant |
Haeleon Medical, Inc. |
1090 lawrence dr |
newbury park,
CA
91320
|
|
Regulation Number | 864.9245
|
Classification Product Code |
|
Date Received | 01/27/2020 |
Decision Date | 08/06/2020 |
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
|
|
|