The following data is part of a premarket notification filed by Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I) with the FDA for Mmrna Appliance.
| Device ID | K210203 |
| 510k Number | K210203 |
| Device Name: | MmRNA Appliance |
| Classification | Device, Anti-snoring |
| Applicant | Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I) 9137 S. Ridgeline Blvd. Suite 135 Highland Ranch, CO 80129 |
| Contact | Catheryn Bonar |
| Correspondent | Colette Cozean Colette Cozean, PhD 21581 Midcrest Dr. Lake Forest, CA 92630 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-26 |
| Decision Date | 2021-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810002220111 | K210203 | 000 |