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510(k) K201931

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) by Dixi Medical — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2021
Date Received
July 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cortical
Device Class
Class II
Regulation Number
882.1310
Review Panel
NE
Submission Type

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