Device Classification Name |
syringe, piston
|
510(k) Number |
BK070069 |
Tradename |
Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System
|
Device Name |
Syringe, piston |
Original Applicant |
Arthrex, Inc. |
1370 creekside boulevard |
naples,
FL
34108
|
|
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 12/10/2007 |
Decision Date | 12/12/2008 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
General Hospital
|
Review Advisory Committee |
General Hospital
|
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
|
|
|