The following data is part of a premarket notification filed by Northwest Orthodontics, Inc. with the FDA for Snap-way Headgear.
| Device ID | K800748 |
| 510k Number | K800748 |
| Device Name: | SNAP-WAY HEADGEAR |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | NORTHWEST ORTHODONTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-04 |
| Decision Date | 1980-04-10 |