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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name oral removable retainer for weight management
De Novo Number DEN150033
Device Name Sensor Monitored Alimentary Restriction Therapy (SMART) Device
Requester
scientific intake
2859 paces ferry road
suite 1710
atlanta,  GA  30339
Contact william longley
Regulation Number876.5981
Classification Product Code
ONY  
Date Received07/31/2015
Decision Date 09/26/2016
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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