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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 foam or gel chemical sterilant/high level disinfectant
De Novo Number DEN220041
Device Name Tristel Duo ULT
Requester
tristel solutions limited
unit 1b, lynx business park, fordham road,
snailwell,  GB cb8 7ny
Contact julija shabanova
Regulation Number880.6886
Classification Product Code
QWS  
Date Received06/29/2022
Decision Date 06/02/2023
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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