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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 orally ingested transient device for constipation
De Novo Number DEN210052
Device Name Vibrant System
Requester
vibrant, ltd.
hakochav p.o. box 516
yokneam,  IL 2069206
Contact lior ben tsur
Regulation Number876.5940
Classification Product Code
QTN  
Date Received11/30/2021
Decision Date 08/26/2022
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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