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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 Blvd.
Suite 400
Duluth,  GA  30097
Applicant Contact DEANNA L BAXAM
Correspondent
Family Dental Services, P.C.
2180 Satellite Blvd.
Suite 400
Duluth,  GA  30097
Correspondent 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 (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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