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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oral removable retainer for weight management
510(k) Number K171165
Device Name SmartByte Device
Scientific Intake
280 Merrimack Street Suite 503
lawrence,  MA  01843
Applicant Contact marc gibeley
Hogan Lovells US LLP
1835 Market Street, 29th Floor
philadelphia,  PA  19103
Correspondent Contact janice m. hogan
Regulation Number876.5981
Classification Product Code
Date Received04/20/2017
Decision Date 05/18/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No