Bruxor
Mouthguard, Over-the-counter
Sleep Specialties, LLC
The following data is part of a premarket notification filed by Sleep Specialties, Llc with the FDA for Bruxor.
Pre-market Notification Details
| Device ID | K172452 |
| 510k Number | K172452 |
| Device Name: | Bruxor |
| Classification | Mouthguard, Over-the-counter |
| Applicant | Sleep Specialties, LLC 2565 South Las Vegas Blvd.,Suite #184 Las Vegas, NV 89109 |
| Contact | James S. Fallon |
| Correspondent | James Smith James Smith 28591 Springfield Drive Laguna Niguel, CA 92677 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-14 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
Trademark Results [Bruxor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRUXOR 87428573 5471636 Live/Registered |
James S. Fallon 2017-04-27 |
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