K203606 is an FDA 510(k) clearance for the Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA). This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Meris Investment Group (Lakeland, US). The FDA issued a Cleared decision on March 10, 2021, 90 days after receiving the submission on December 10, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K203606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2020 |
| Decision Date | March 10, 2021 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| 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 |