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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, cortical
510(k) Number K201931
Device Name Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
Applicant
Dixi Medical
2A Route de Pouligney
Chaudefontaine,  FR 25640
Applicant Contact Lucie Petegnief
Correspondent
Domecus Consulting Services LLC
1171 Barroilhet Drive
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number882.1310
Classification Product Code
GYC  
Date Received07/13/2020
Decision Date 10/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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