Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K150566 |
Device Name |
Oniris |
Applicant |
SAS Oniris |
704 Avenue Roger Salengro |
CHAVILLE,
FR
92370
|
|
Applicant Contact |
Thibault Vincent |
Correspondent |
SAS Oniris |
704 Avenue Roger Salengro |
CHAVILLE,
FR
92370
|
|
Correspondent Contact |
Thibault Vincent |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 03/06/2015 |
Decision Date | 03/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|