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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cortical
510(k) Number K211954
Device Name Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
Applicant
Spes Medica SRL
Via Europa -Zona Industriale
Battipaglia,  IT 84091
Applicant Contact Giorgio Facco
Correspondent
Spes Medica SRL
Via Europa - Zona Industriale
Battipaglia,  IT 84091
Correspondent Contact Giorgio Facco
Regulation Number882.1310
Classification Product Code
GYC  
Date Received06/23/2021
Decision Date 11/10/2022
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
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