Device Classification Name |
mesh, surgical, metal
|
510(k) Number |
K900138 |
Device Name |
MOTECH TITANIUM SURGICAL MESH |
Applicant |
BIEDERMANN MOTECH GMBH |
18159 VILLAGE MART DR. |
SUITE 243 |
OLNEY,
MD
20832
|
|
Applicant Contact |
ARTHUR B MCINTYRE |
Correspondent |
BIEDERMANN MOTECH GMBH |
18159 VILLAGE MART DR. |
SUITE 243 |
OLNEY,
MD
20832
|
|
Correspondent Contact |
ARTHUR B MCINTYRE |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 01/11/1990 |
Decision Date | 03/20/1990 |
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
|
|
|