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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
DYNAFLEX
611 WEST 5TH STREET
THIRD FLOOR
AUSTIN,  TX  78701
Applicant Contact STUART R GOLDMAN
Correspondent
DYNAFLEX
611 WEST 5TH STREET
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
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