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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 cooperative powered surgical assist device for ent surgery
De Novo Number DEN220047
Device Name Galen ES Cooperative Surgical Assistant Platform, Galen ES
Requester
galen robotics
1100 wicomico st., ste. 725
baltimore,  MD  21230
Contact robert lawery
Regulation Number874.4460
Classification Product Code
QXG  
Date Received07/22/2022
Decision Date 07/19/2023
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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