Device Classification Name |
mesh, surgical, metal
|
510(k) Number |
K896369 |
Device Name |
TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM |
Applicant |
TECHMEDICA, INC. |
1380 FLYNN RD. |
CAMARILLO,
CA
93010
|
|
Applicant Contact |
GARY KELSEY |
Correspondent |
TECHMEDICA, INC. |
1380 FLYNN RD. |
CAMARILLO,
CA
93010
|
|
Correspondent Contact |
GARY KELSEY |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/06/1989 |
Decision Date | 11/24/1989 |
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
|
|
|