K780747 is an FDA 510(k) clearance for the SNAP-WAY. 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 May 26, 1978, 18 days after receiving the submission on May 8, 1978.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5500.
| 510(k) Number | K780747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1978 |
| Decision Date | May 26, 1978 |
| Days to Decision | 18 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 |