The following data is part of a premarket notification filed by Panthera Dental Inc. with the FDA for The Panthera Anti-snoring Device.
| Device ID | K143244 |
| 510k Number | K143244 |
| Device Name: | The Panthera Anti-Snoring Device |
| Classification | Device, Anti-snoring |
| Applicant | Panthera Dental Inc. 2035 Rue De Haut-Bord Quebec, CA G1n 4r7 |
| Contact | Guy Bernard Bantsiele |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-11-12 |
| Decision Date | 2014-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540204000015 | K143244 | 000 |