The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Intraoral Mandibular Distraction Device.
| Device ID | K970256 |
| 510k Number | K970256 |
| Device Name: | INTRAORAL MANDIBULAR DISTRACTION DEVICE |
| Classification | Plate, Bone |
| Applicant | MEDICON, E.G. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein, Esq. |
| Correspondent | Howard M Holstein, Esq. MEDICON, E.G. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-23 |
| Decision Date | 1997-03-11 |