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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 surgical smoke precipitator
De Novo Number DEN150022
Device Name Ultravision Visual Clearing System
Requester
alesi surgical ltd.
suite 18, cardiff medical centre, heath park
caediff,  GB
Contact dominic griffiths
Regulation Number878.5050
Classification Product Code
PQM  
Date Received05/26/2015
Decision Date 12/20/2016
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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