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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 Ste 190
Frisco,  TX  75034
Applicant Contact KATHRYN A JAYNE
Correspondent
SOMNOMED INC.
7460 Warren Pkwy Ste 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
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