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510(k) K221123

WISE Cortical Strip (WCS) by Wise S.R.L. — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2022
Date Received
April 18, 2022
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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