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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 K261366
Device Name Virtus
Applicant
Somnomed, Inc.
6513 Windcrest Dr., Suite 100
Plano,  TX  75024
Applicant Contact Mary Kennell
Correspondent
Somnomed, Inc.
6513 Windcrest Dr., Suite 100
Plano,  TX  75024
Correspondent Contact Hai Tei Tan
Regulation Number872.5570
Classification Product Code
LRK  
Date Received04/27/2026
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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