The following data is part of a premarket notification filed by Fbcc Inc with the FDA for Fbcc Night Guard.
| Device ID | K221369 |
| 510k Number | K221369 |
| Device Name: | FBCC Night Guard |
| Classification | Mouthguard, Over-the-counter |
| Applicant | FBCC Inc 6711 S Sepulveda Blvd, Unit 602 Los Angeles, CA 90045 |
| Contact | Pablo Osorio |
| Correspondent | Elisabeth Miller Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, TX 77043 |
| 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 | 2022-05-12 |
| Decision Date | 2022-11-18 |