| Device Classification Name |
device, anti-snoring |
|||
|---|---|---|---|---|
| 510(k) Number | K111207 | |||
| Device Name | RESPIRE BLUE SERIES | |||
| Applicant |
|
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| Applicant Contact | daniela levy | |||
| Correspondent |
|
|||
| Correspodent Contact | daniela levy | |||
| Regulation Number | 872.5570 | |||
| Classification Product Code |
|
|||
| Date Received | 04/29/2011 | |||
| Decision Date | 08/23/2011 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Dental |
|||
| 510k Review Panel |
Dental |
|||
| summary |
summary |
|||
| Type | Abbreviated | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |