The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Somnodent Alpha.
| Device ID | K162306 |
| 510k Number | K162306 |
| Device Name: | SomnoDent ALPHA |
| Classification | Device, Anti-snoring |
| Applicant | SomnoMed Inc. 7460 Warren Pkwy Ste 190 Frisco, TX 75034 |
| Contact | Kien Nguyen |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-08-17 |
| Decision Date | 2016-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851826007182 | K162306 | 000 |