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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
Predetermined Change
Control Plan Authorized		 No
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