K033823 is an FDA 510(k) clearance for the RESPIRONICS CUSTOM II ORAL APPLIANCE. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on February 6, 2004, 58 days after receiving the submission on December 10, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K033823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2003 |
| Decision Date | February 06, 2004 |
| Days to Decision | 58 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK — Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |