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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K180691
Device Name TrueDorsal Devices
Applicant
True Function Laboratory, Inc.
7851 University Ave., #102
La Mesa,  CA  91942
Applicant Contact Frank Madrigal
Correspondent
Azar & Associates
P.O. Box 800914
Santa Clarita,  CA  91380
Correspondent Contact Nicolas Azar
Regulation Number872.5570
Classification Product Code
LRK  
Date Received03/16/2018
Decision Date 02/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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