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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 St. NW, Suite 1340
Albuquerque,  NM  87102
Applicant Contact JANEEN VILVEN-DOGGETT
Correspondent
Distar, LLC
201 Third St. 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
Predetermined Change
Control Plan Authorized		 No
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