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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 DEN250013
Device Name Modius Spero
Requester
neurovalens limited
8 carmagrim rd.
portglenone,  GB bt44 8bp
Contact jason mckeown
Classification Product Code
SHX
Date Received04/16/2025
Decision Date 05/08/2026
Decision granted (DENG)
Review Advisory Committee Neurology
Type Direct
Predetermined Change
Control Plan Authorized		 No
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