The following data is part of a premarket notification filed by Village Park Orthodontics with the FDA for Elastomeric Sleep Appliance.
| Device ID | K946112 |
| 510k Number | K946112 |
| Device Name: | ELASTOMERIC SLEEP APPLIANCE |
| Classification | Device, Jaw Repositioning |
| Applicant | VILLAGE PARK ORTHODONTICS 16 SUFFIELD AVE. Depew, NY 14043 |
| Contact | Stephen P Warunek |
| Correspondent | Stephen P Warunek VILLAGE PARK ORTHODONTICS 16 SUFFIELD AVE. Depew, NY 14043 |
| Product Code | LQZ |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-15 |
| Decision Date | 1995-06-14 |