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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 K121340
Device Name SOMNODENT G2
Original Applicant
7460 warren pkwy ste 190
frisco,  TX  75034
Original Contact kathryn jayne
Regulation Number872.5570
Classification Product Code
Date Received05/03/2012
Decision Date 05/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No