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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 computerized behavioral therapy device for treating symptoms
De Novo Number DEN200029
Device Name Parallel
Requester
mahana therapeutics, inc.
230 california st.
suite 302
san francisco,  CA  94111
Contact jean-noel courvoisier
Regulation Number876.5960
Classification Product Code
QMY  
Date Received04/30/2020
Decision Date 11/25/2020
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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