The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Somnodent Fusion, Classic; Somnodent Fusion, Flex.
| Device ID | K140278 |
| 510k Number | K140278 |
| Device Name: | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX |
| Classification | Device, Anti-snoring |
| Applicant | SOMNOMED INC. 7460 Warren Pkwy Ste 190 Frisco, TX 75034 |
| Contact | Kathryn A Jayne |
| Correspondent | Kathryn A Jayne SOMNOMED INC. 7460 Warren Pkwy Ste 190 Frisco, TX 75034 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-03 |
| Decision Date | 2014-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851826007052 | K140278 | 000 |
| 00851826007045 | K140278 | 000 |