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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 hemostatic device for endoscopic gastrointestinal use
De Novo Number DEN170015
Device Name Hemospray Endoscopic Hemostat
Requester
wilson-cook medical, inc.
4900 bethania station rd.
winston-salem,  NC  27105
Contact marge walls-walker
Regulation Number878.4456
Classification Product Code
QAU  
Date Received03/09/2017
Decision Date 05/07/2018
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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