The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Medicon 2.4 Mandibular Reconstruction Plating System.
| Device ID | K043297 |
| 510k Number | K043297 |
| Device Name: | MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM |
| Classification | Plate, Bone |
| Applicant | MEDICON, E.G. AMSTEL 320-1 Amsterdam, NL 1017ap |
| Contact | Angelika Scherp |
| Correspondent | Angelika Scherp MEDICON, E.G. AMSTEL 320-1 Amsterdam, NL 1017ap |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-29 |
| Decision Date | 2005-02-23 |
| Summary: | summary |