Device Classification Name |
Syringe, Piston
|
510(k) Number |
K121124 |
Device Name |
ARTHREX MIXING AND DELIVERY SYSTEM |
Applicant |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Applicant Contact |
CHRISTINA FLORES |
Correspondent |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Correspondent Contact |
CHRISTINA FLORES |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 04/13/2012 |
Decision Date | 05/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|