Device Classification Name |
motor, surgical instrument, ac-powered
|
510(k) Number |
K012738 |
Device Name |
SYMPHONY GRAFT DELIVERY SYSTEM (GDS) |
Applicant |
DEPUY ACROMED |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Applicant Contact |
KAREN F JURCZAK |
Correspondent |
DEPUY ACROMED |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Correspondent Contact |
KAREN F JURCZAK |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 08/16/2001 |
Decision Date | 11/14/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|