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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 K083209
Device Name ACRYLIC HERBST SPLINT APPLIANCE
Applicant
SPECIALTY APPLIANCE WORKS, INC.
4905 HAMMOND INDUSTRIAL DRIVE
CUMMING,  GA  30041
Applicant Contact CAROLYN THOMAS
Correspondent
SPECIALTY APPLIANCE WORKS, INC.
4905 HAMMOND INDUSTRIAL DRIVE
CUMMING,  GA  30041
Correspondent Contact CAROLYN THOMAS
Regulation Number872.5570
Classification Product Code
LRK  
Date Received10/31/2008
Decision Date 01/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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