The following data is part of a premarket notification filed by Biedermann Motech Gmbh with the FDA for Motech Titanium Surgical Mesh.
| Device ID | K900138 |
| 510k Number | K900138 |
| Device Name: | MOTECH TITANIUM SURGICAL MESH |
| Classification | Mesh, Surgical, Metal |
| Applicant | BIEDERMANN MOTECH GMBH 18159 VILLAGE MART DR. SUITE 243 Olney, MD 20832 |
| Contact | Arthur B Mcintyre |
| Correspondent | Arthur B Mcintyre BIEDERMANN MOTECH GMBH 18159 VILLAGE MART DR. SUITE 243 Olney, MD 20832 |
| Product Code | EZX |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-11 |
| Decision Date | 1990-03-20 |