The following data is part of a premarket notification filed by Somnomed Inc with the FDA for Somnobrux Splints.
| Device ID | K102909 |
| 510k Number | K102909 |
| Device Name: | SOMNOBRUX SPLINTS |
| Classification | Mouthguard, Prescription |
| Applicant | SOMNOMED INC 7460 WARREN PARKWAY SUITE 190 Frisco, TX 75034 |
| Contact | Bradley Southworth |
| Correspondent | Bradley Southworth SOMNOMED INC 7460 WARREN PARKWAY SUITE 190 Frisco, TX 75034 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-01 |
| Decision Date | 2011-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851826007151 | K102909 | 000 |