The following data is part of a premarket notification filed by Bryan Keropian Dds with the FDA for Full Breath Sleep Appliance - Ab (anterior Bite).
Device ID | K052862 |
510k Number | K052862 |
Device Name: | FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) |
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 | 2005-10-11 |
Decision Date | 2005-12-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D85463252S1 | K052862 | 000 |
D85463251S1 | K052862 | 000 |
D85463250TS1 | K052862 | 000 |
D85463250SLS1 | K052862 | 000 |
D85463250S1 | K052862 | 000 |
D85463250PS1 | K052862 | 000 |
D85463250AS1 | K052862 | 000 |
D85463250AHS1 | K052862 | 000 |