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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 K170959
Device Name DIXI Medical Microdeep Depth Electrode
Applicant
Dixi Medical
2a Route De Pouligney
Chaudefontaine,  FR
Applicant Contact Lucie Petegnief
Correspondent
Experien Group, LLC
224 Airport Pkwy., Suite 250
San Jose,  CA  95110
Correspondent Contact Valerie Defiesta-Ng
Regulation Number882.1330
Classification Product Code
GZL  
Date Received03/31/2017
Decision Date 11/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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