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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 powered fecal management system
De Novo Number DEN250043
Device Name Qoramatic Automated Stool Management
Requester
cm technologies, inc.
1321 valwood pkwy.
suite 530
carrollton,  TX  75006
Contact nishith chasmawala
Regulation Number876.5230
Classification Product Code
SJB  
Date Received09/15/2025
Decision Date 08/20/2026
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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