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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
Applicant Contact DEANNA L BAXAM
Correspondent
FAMILY DENTAL SERVICES, P.C.
2180 SATELLITE BOULEVARD
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
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