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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 K113516
Device Name THERASOM-CAST
Applicant
FAMILY DENTAL SERVICES, P.C.
2180 satellite boulevard
suite 400
duluth,  GA  30097
Contact deanna l baxam
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received11/29/2011
Decision Date 01/04/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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