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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 electromechanical system for open microsurgery
De Novo Number DEN230032
Device Name Symani Surgical System
Requester
mmi north america, inc.
344 ponte vedra blvd.
ponte vedra,  FL  32082
Contact mauro ercolani
Regulation Number878.4963
Classification Product Code
SAQ  
Date Received04/25/2023
Decision Date 04/05/2024
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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