The following data is part of a premarket notification filed by Meris Investment Group with the FDA for Serena Sleep Block Mandibular Advancement (bma), Serena Sleep Elastic Mandibular Advancement (ema).
| Device ID | K203606 |
| 510k Number | K203606 |
| Device Name: | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) |
| Classification | Device, Anti-snoring |
| Applicant | Meris Investment Group 16688 7th Street South Lakeland, MN 55043 |
| Contact | Gary Maas |
| Correspondent | Sarah Moss Medavice, Inc 11218 Zest Ct NE Blaine, MN 55449 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-10 |
| Decision Date | 2021-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005753079 | K203606 | 000 |
| 00860005753062 | K203606 | 000 |
| 00860005753055 | K203606 | 000 |
| 00860005753048 | K203606 | 000 |
| 00860005753024 | K203606 | 000 |
| 00860005753000 | K203606 | 000 |