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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 K140663
Device Name THERASNORE
Applicant
DISTAR, LLC
201 third street nw, suite 1340
albuquerque,  NM  87102
Applicant Contact janeen vilven-doggett
Correspondent
DISTAR, LLC
201 third street nw, suite 1340
albuquerque,  NM  87102
Correspondent Contact janeen vilven-doggett
Regulation Number872.5570
Classification Product Code
LRK  
Date Received03/18/2014
Decision Date 12/12/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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