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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 K111179
Device Name ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
Applicant
Siesta Medical, Inc.
101 Church St., Suite 3
Los Gatos,  CA  95030
Applicant Contact MICHAEL KOLBER
Correspondent
Siesta Medical, Inc.
101 Church St., Suite 3
Los Gatos,  CA  95030
Correspondent Contact MICHAEL KOLBER
Regulation Number872.5570
Classification Product Code
ORY  
Date Received04/27/2011
Decision Date 07/01/2011
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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