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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 flushing solution for short term storage of veins at room temperature during coronary artery bypass graft surgeries
De Novo Number DEN230002
Device Name DuraGraft
Requester
Marizyme, Inc.
555 heritage drive,
suite 205
jupiter,  FL  33458
Contact navdeep kaur cheema
Regulation Number876.4100
Classification Product Code
QEJ  
Date Received01/03/2023
Decision Date 10/04/2023
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
Type Direct
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