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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 surgical system wherein the surgeon annd the user interface can be in the sterile field
De Novo Number DEN230084
Device Name Dexter L6 System
Requester
distalmotion, sa
route de la corniche 3b
epalinges,  CH 1066
Contact larry carrier
Regulation Number878.4965
Classification Product Code
SDD  
Date Received12/15/2023
Decision Date 10/25/2024
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
Type Direct
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