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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 endoscopic pancreatic debridement device
De Novo Number DEN200016
Device Name EndoRotor Device
Requester
interscope, inc.
100 main st., suite 108
whitinsville,  MA  01588
Contact jeffery ryan
Regulation Number876.4330
Classification Product Code
QNE  
Date Received03/16/2020
Decision Date 12/23/2020
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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