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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
Spes Medica SRL
Via Europa -Zona Industriale
Battipaglia,  IT 84091
Applicant Contact Giorgio Facco
Spes Medica SRL
Via Europa - Zona Industriale
Battipaglia,  IT 84091
Correspondent Contact Giorgio Facco
Regulation Number882.1310
Classification Product Code
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