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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 DEN250026
Device Name Avulux
Requester
matap ii, llc
18117 biscayne blvd.
suite 125
aventura,  FL  33160
Contact charles posternack
Classification Product Code
QEO
Date Received06/23/2025
Decision Date 08/21/2026
Decision granted (DENG)
Review Advisory Committee Neurology
Type Direct
Predetermined Change
Control Plan Authorized		 No
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