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 |