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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 K213159
Device Name Encore System
Applicant
Siesta Medical, Inc.
101 Church Street
Los Gatos,  CA  95030
Applicant Contact Michael Kolber
Correspondent
Siesta Medical, Inc.
101 Church Street
Los Gatos,  CA  95030
Correspondent Contact Michael Kolber
Regulation Number872.5570
Classification Product Code
ORY  
Date Received09/28/2021
Decision Date 12/22/2021
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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