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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 anal fistula closure device
De Novo Number DEN240007
Device Name BioHealx Anal Fistula Device
Requester
signum surgical limited
galway harbour enterprise par, new docks, the docks
galway,  IE h91 nny6
Contact moshe zilversmit
Regulation Number878.4835
Classification Product Code
QML  
Date Received02/02/2024
Decision Date 07/01/2024
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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