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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 diagnostic neurosurgical microscope filter
De Novo Number DEN180024
Device Name Leica FL400
Leica Microsystems (Schweiz) AG
max schmidheiny-strasse 201
heerbrugg,  CH 9435
Contact grainne griffin
Regulation Number882.4950
Classification Product Code
Date Received04/27/2018
Decision Date 03/28/2019
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct