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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prelude tongue suspension system
510(k) Number K121814
Model FG0002
Device Name ENCORE TONGUE SUSPENSION SYSTEM
Original Applicant
SIESTA MEDICAL, INC.
101 church street
suite 3
los gatos,  CA  95030
Original Contact michael kolber
Regulation Number872.5570
Classification Product Code
ORY  
Date Received06/20/2012
Decision Date 11/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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