The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Somnodent G2.
| Device ID | K121340 |
| 510k Number | K121340 |
| Device Name: | SOMNODENT G2 |
| Classification | Device, Anti-snoring |
| Applicant | SOMNOMED INC. 7460 Warren Pkwy Ste 190 Frisco, TX 75034 |
| Contact | Kathryn Jayne |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-05-03 |
| Decision Date | 2012-05-30 |
| Summary: | summary |