The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Titanium Mandibulat Reconstruction System.
| Device ID | K951689 |
| 510k Number | K951689 |
| Device Name: | TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM |
| Classification | Plate, Bone |
| Applicant | MEDICON, E.G. 24301 ROBERTS DR. SUITE C Black Diamond, WA 98010 |
| Contact | Dennis Youde |
| Correspondent | Dennis Youde MEDICON, E.G. 24301 ROBERTS DR. SUITE C Black Diamond, WA 98010 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-05 |
| Decision Date | 1995-07-27 |