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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 K121440
Device Name ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
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 Received05/15/2012
Decision Date 12/06/2012
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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