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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 K221123
Device Name WISE Cortical Strip (WCS)
Applicant
WISE S.r.l.
Via Michelangelo Buonarroti ,38
Cologno Monzese,  IT 20093
Applicant Contact Luca Ravagnan
Correspondent
Decus Biomedical
2342 Shattuck Ave #333
Berkeley,  CA  94704
Correspondent Contact Terri Bogucki
Regulation Number882.1310
Classification Product Code
GYC  
Date Received04/18/2022
Decision Date 11/22/2022
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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