The following data is part of a premarket notification filed by Panthera Dental Inc. with the FDA for The Panthera Anti-snoring X3 Device.
| Device ID | K171576 |
| 510k Number | K171576 |
| Device Name: | The Panthera Anti-Snoring X3 Device |
| Classification | Device, Anti-snoring |
| Applicant | Panthera Dental Inc. 2035, Rue Du Haut-Bord Quebec City, CA G1n 4n7 |
| Contact | Martine Fortin |
| Correspondent | Martine Fortin Panthera Dental Inc. 2035, Rue Du Haut-Bord Quebec City, CA G1n 4n7 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-30 |
| Decision Date | 2018-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540204000022 | K171576 | 000 |