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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 K103076
Device Name DYNAFLEX
Applicant
Dyna Flex
611 W. 5th St. Third Floor
Austin,  TX  78701
Applicant Contact STUART R GOLDMAN
Correspondent
Dyna Flex
611 W. 5th St. Third Floor
Austin,  TX  78701
Correspondent Contact STUART R GOLDMAN
Regulation Number872.5570
Classification Product Code
LRK  
Date Received10/18/2010
Decision Date 02/23/2011
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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