The Panthera Anti-Snoring Device

Device, Anti-snoring

Panthera Dental Inc.

The following data is part of a premarket notification filed by Panthera Dental Inc. with the FDA for The Panthera Anti-snoring Device.

Pre-market Notification Details

Device IDK143244
510k NumberK143244
Device Name:The Panthera Anti-Snoring Device
ClassificationDevice, Anti-snoring
Applicant Panthera Dental Inc. 2035 Rue De Haut-Bord Quebec,  CA G1n 4r7
ContactGuy Bernard Bantsiele
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York,  NY  10111
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-11-12
Decision Date2014-12-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07540204000015 K143244 000
07540204000060 K143244 000
07540204000053 K143244 000

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