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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 extracorporeal system for carbon dioxide removal
De Novo Number DEN210006
Device Name Hemolung Respiratory Assist System
Requester
alung technologies, inc.
2500 jane street, suite 1
pittsburgh,  PA  15203
Contact joe argyros
Regulation Number870.4150
Classification Product Code
QOH  
Date Received03/04/2021
Decision Date 11/13/2021
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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