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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tongue suspension system
510(k) Number K201238
Device Name Encore System
Applicant
Siesta Medical, Inc.
101 Church Street, Suite 3
Los Gatos,  CA  95030
Applicant Contact Michael Kolber
Correspondent
Siesta Medical, Inc.
101 Church Street, Suite 3
Los Gatos,  CA  95030
Correspondent Contact Michael Kolber
Regulation Number872.5570
Classification Product Code
ORY  
Date Received05/07/2020
Decision Date 10/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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