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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K202087
FOIA Releasable 510(k) K202087
Device Name DIXI Medical Microdeep Micro-Macro Depth Electrodes
Applicant
Dixi Medical
2A Route de Pouligney
Chaudefontaine,  FR 25640
Applicant Contact Lucie Petegnief
Correspondent
Domecus Consulting Services LLC
145 Howland Pines Drive
Oxford,  MI  48371
Correspondent Contact Steve Plymale
Regulation Number882.1330
Classification Product Code
GZL  
Date Received07/28/2020
Decision Date 11/18/2021
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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