TrueDorsal Devices

Device, Anti-snoring

True Function Laboratory, Inc.

The following data is part of a premarket notification filed by True Function Laboratory, Inc. with the FDA for Truedorsal Devices.

Pre-market Notification Details

Device IDK180691
510k NumberK180691
Device Name:TrueDorsal Devices
ClassificationDevice, Anti-snoring
Applicant True Function Laboratory, Inc. 7851 University Ave., #102 La Mesa,  CA  91942
ContactFrank Madrigal
CorrespondentNicolas Azar
Azar & Associates PO Box 800914 Santa Clarita,  CA  91380 -0914
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-16
Decision Date2019-02-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860001703016 K180691 000

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