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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 electrosurgical clip cutting system
De Novo Number DEN160014
Device Name remOVE System
Requester
ovesco endoscopy ag
dorfackerstrasse 26
tuebingen,  DE 72074
Contact med.marc o. schurr
Regulation Number876.4310
Classification Product Code
QAG  
Date Received04/11/2016
Decision Date 12/22/2017
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
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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