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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 enzyme packed cartridge
De Novo Number DEN150001
Device Name RELIZORB
Requester
alcresta, inc.
one newton executive park, suite 202
newton,  MA  02462
Contact robert gallotto
Regulation Number876.5985
Classification Product Code
PLQ  
Date Received01/02/2015
Decision Date 11/20/2015
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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