The following data is part of a premarket notification filed by Bryan Keropian Dds with the FDA for Full Breath Sleep Appliance With Posterior Tongue Depressor.
| Device ID | K061228 |
| 510k Number | K061228 |
| Device Name: | FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR |
| Classification | Device, Jaw Repositioning |
| Applicant | BRYAN KEROPIAN DDS 18607 VENTURA BLVD., SUITE 206 Tarzana, CA 91356 |
| Contact | Bryan Keropian, Dds |
| Correspondent | Bryan Keropian, Dds BRYAN KEROPIAN DDS 18607 VENTURA BLVD., SUITE 206 Tarzana, CA 91356 |
| Product Code | LQZ |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-02 |
| Decision Date | 2006-05-26 |
| Summary: | summary |