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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 pediatric hemodialysis system
De Novo Number DEN180055
Device Name CARPEDIEM System
Requester
Bellco srl (now part of Medtronic, Inc)
via camurana 1
mirandola,  IT 41037
Contact matteo chiappini
Regulation Number876.5861
Classification Product Code
QIR  
Date Received10/09/2018
Decision Date 04/29/2020
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
Type Direct
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