Device Classification Name |
platelet and plasma separator for bone graft handling
|
510(k) Number |
BK110035 |
Tradename |
TropoCells Autologous Platelet Preparation Kit
|
Device Name |
Platelet And Plasma Separator For Bone Graft Handling |
Original Applicant |
Estar Technologies LTD |
420 lexington avenue |
suite 2400 |
new york,
NY
10170
|
|
Regulation Number | 864.9245
|
Classification Product Code |
|
Date Received | 07/18/2011 |
Decision Date | 03/28/2012 |
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
|