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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 K972061
Device Name TOA
Applicant
W. Keith Thornton, D.D.S.
6131 Luther Lane, Suite 208
Dallas,  TX  75225
Applicant Contact W. KEITH THORNTON
Correspondent
W. Keith Thornton, D.D.S.
6131 Luther Lane, Suite 208
Dallas,  TX  75225
Correspondent Contact W. KEITH THORNTON
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/03/1997
Decision Date 08/21/1997
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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