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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
SOMNOMED INC.
7460 warren pkwy ste 190
frisco,  TX  75034
Original Contact kathryn jayne
Regulation Number872.5570
Classification Product Code
LRK  
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
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