The following data is part of a premarket notification filed by Sas Oniris with the FDA for Oniris.
Device ID | K150566 |
510k Number | K150566 |
Device Name: | Oniris |
Classification | Device, Anti-snoring |
Applicant | SAS Oniris 704 Avenue Roger Salengro Chaville, FR 92370 |
Contact | Thibault Vincent |
Correspondent | Thibault Vincent SAS Oniris 704 Avenue Roger Salengro Chaville, FR 92370 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-06 |
Decision Date | 2016-03-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ONIRIS 79160891 4788002 Live/Registered |
ONIRIS 2014-12-23 |
ONIRIS 79160891 4788002 Live/Registered |
Mathieu VINCENT 2014-12-23 |
ONIRIS 79160891 4788002 Live/Registered |
Thibault VINCENT 2014-12-23 |