Device Classification Name |
Mesh, Surgical, Metal
|
510(k) Number |
K890601 |
Device Name |
STUART TITANIUM SURGICAL MESH |
Applicant |
STUART |
ONE STUART PLAZA |
DONOHUE/LUXOR ROADS |
GREENSBURG,
PA
15601
|
|
Applicant Contact |
ABRAHAM GLASSER |
Correspondent |
STUART |
ONE STUART PLAZA |
DONOHUE/LUXOR ROADS |
GREENSBURG,
PA
15601
|
|
Correspondent Contact |
ABRAHAM GLASSER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 02/06/1989 |
Decision Date | 03/16/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|