Device Classification Name |
Mesh, Surgical, Metal
|
510(k) Number |
K032282 |
Device Name |
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM |
Applicant |
IMPLEX CORP. |
80 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Applicant Contact |
MARCI HALEVI |
Correspondent |
IMPLEX CORP. |
80 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Correspondent Contact |
MARCI HALEVI |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/24/2003 |
Decision Date | 08/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|