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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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De Novo Number DEN240075
Device Name Prolystica Pass Thru Disinfectant Wipes
Requester
steris
5960 heisley rd.
mentor,  OH  44060
Contact steve elliott
Classification Product Code
SHM
Date Received12/12/2024
Decision Date 05/01/2026
Decision granted (DENG)
Review Advisory Committee General Hospital
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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