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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K243788
Device Name IceCap product line
Applicant
Bioserenity Medical Devices Group
20, Rue Berbier Du Mets
Paris Cedex 13 Lle-De-France
Paris,  FR 75013
Applicant Contact Melanie Renaud-Samiri
Correspondent
Bioserenity Medical Devices Group
20, Rue Berbier Du Mets
Paris Cedex 13 Lle-De-France
Paris,  FR 75013
Correspondent Contact Aude Gourgues
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/09/2024
Decision Date 03/13/2025
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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