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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 esophageal, mucosal, electrical characterization
De Novo Number DEN180067
Device Name Mucosal Integrity Conductivity (MI) Test System
Requester
diversatek healthcare inc.
9150 commerce center circle, suite 500
highlands ranch,  CO  80129
Contact laura l boll
Regulation Number876.1450
Classification Product Code
QIS  
Date Received12/17/2018
Decision Date 12/23/2019
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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