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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K153291
Device Name SICAT OPTISLEEP
Applicant
Sicat GmbH & Co. KG
Brunnenallee 6
Bonn,  DE 53177
Applicant Contact MANFRED BREUER
Correspondent
Sicat GmbH & Co. KG
Brunnenallee 6
Bonn,  DE 53177
Correspondent Contact MANFRED BREUER
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received11/13/2015
Decision Date 03/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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