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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 K183443
Device Name SomnoDent Avant
Applicant
Somnomed, Inc.
6513 Windcrest Dr.
Plano,  TX  75024
Applicant Contact Dorene Markwiese
Correspondent
Somnomed, Inc.
6513 Windcrest Dr.
Plano,  TX  75024
Correspondent Contact Dorene Markwiese
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
PLC  
Date Received12/12/2018
Decision Date 05/08/2019
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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