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 |