The following data is part of a premarket notification filed by Howmedica Leibinger, Inc. with the FDA for Vazquez Diner Intraoral Distraction Device.
| Device ID | K964649 |
| 510k Number | K964649 |
| Device Name: | VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE |
| Classification | Plate, Bone |
| Applicant | HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Contact | Kristyn R Waski |
| Correspondent | Kristyn R Waski HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-20 |
| Decision Date | 1997-01-24 |
| Summary: | summary |