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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 K140278
Device Name SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
Applicant
Somnomed, Inc.
7460 Warren Pkwy. Suite 190
Frisco,  TX  75034
Applicant Contact KATHRYN A JAYNE
Correspondent
Somnomed, Inc.
7460 Warren Pkwy. Suite 190
Frisco,  TX  75034
Correspondent Contact KATHRYN A JAYNE
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/03/2014
Decision Date 06/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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