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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 blood detection capsule
De Novo Number DEN220065
Device Name Pill Sense System
Requester
enterasense , ltd.
unit 3 ballybrit business park, mervue
galway,  IE h91 dt7c
Contact david collins
Regulation Number876.1390
Classification Product Code
QUD  
Date Received09/29/2022
Decision Date 02/24/2023
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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