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 |