The following data is part of a premarket notification filed by Bryan Keropian Dds with the FDA for Full Breath Sleep Appliance Lower (fbsl).
| Device ID | K091035 |
| 510k Number | K091035 |
| Device Name: | FULL BREATH SLEEP APPLIANCE LOWER (FBSL) |
| Classification | Device, Jaw Repositioning |
| Applicant | BRYAN KEROPIAN DDS 186663 VENTURA BLVD. SUITE 200 Tarzana, CA 91356 |
| Contact | Bryan Keropian |
| Correspondent | Bryan Keropian BRYAN KEROPIAN DDS 186663 VENTURA BLVD. SUITE 200 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 | 2009-04-10 |
| Decision Date | 2009-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D85460994S1 | K091035 | 000 |
| D85463760AS1 | K091035 | 000 |
| D85463760HLS1 | K091035 | 000 |
| D85463760KS1 | K091035 | 000 |
| D85463760S1 | K091035 | 000 |
| D85463760TES1 | K091035 | 000 |
| D85463760TS1 | K091035 | 000 |
| D85463760VHS1 | K091035 | 000 |
| D85466030S1 | K091035 | 000 |
| D85460994LS1 | K091035 | 000 |
| D85463750S1 | K091035 | 000 |