The following data is part of a premarket notification filed by Bryan Keropian Dds with the FDA for Full Breath Sleep Appliance - Pb (posterior Bite And Pbb (posterior Bite With Bumps).
| Device ID | K053065 |
| 510k Number | K053065 |
| Device Name: | FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) |
| Classification | Device, Jaw Repositioning |
| Applicant | BRYAN KEROPIAN DDS 18607 VENTURA BLVD., SUITE 206 Tarzana, CA 91356 |
| Contact | Bryan Keropian |
| Correspondent | Bryan Keropian 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 | 2005-11-01 |
| Decision Date | 2006-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D85463226S1 | K053065 | 000 |
| D85463225AS1 | K053065 | 000 |
| D85463225AHS1 | K053065 | 000 |
| D85463224S1 | K053065 | 000 |