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FDA 510(k) Application Details - K201931
Device Classification Name
Electrode, Cortical
More FDA Info for this Device
510(K) Number
K201931
Device Name
Electrode, Cortical
Applicant
Dixi Medical
2A Route de Pouligney
Chaudefontaine 25640 FR
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Contact
Lucie Petegnief
Other 510(k) Applications for this Contact
Regulation Number
882.1310
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Classification Product Code
GYC
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More FDA Info for this Product Code
Date Received
07/13/2020
Decision Date
10/02/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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