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 |