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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 whole room microbial reduction device
De Novo Number DEN230007
Device Name LightStrike+ (MXSUV1-SL and MXSUV1-FT)
Requester
xenex disinfection services, inc.
1074 arion circle, suite 116
san antonio,  TX  78254
Contact juan l. gonzalez
Regulation Number880.6510
Classification Product Code
QXJ  
Date Received02/01/2023
Decision Date 09/01/2023
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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