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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K212326
Device Name AC Cream - Conductive paste
Applicant
Spes Medica S.r.l
Via Europa-Zona industriale
Battipaglia,  IT 84091
Applicant Contact Giorgio Facco
Correspondent
Spes Medica S.r.l
Via Europa-Zona industriale
Battipaglia,  IT 84091
Correspondent Contact Giorgio Facco
Regulation Number882.1275
Classification Product Code
GYB  
Date Received07/26/2021
Decision Date 12/01/2021
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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