K800748 is an FDA 510(k) clearance for the SNAP-WAY HEADGEAR. This device is classified as a Headgear, Extraoral, Orthodontic (Class II - Special Controls, product code DZB).
Submitted by Northwest Orthodontics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1980, 6 days after receiving the submission on April 4, 1980.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5500.
| 510(k) Number | K800748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1980 |
| Decision Date | April 10, 1980 |
| Days to Decision | 6 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DZB — Headgear, Extraoral, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5500 |