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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 K252439
Device Name Tutamen Self Adhesive Electrodes
Applicant
Dongguan Tutamen Metalwork Co., Ltd.
#3, Huangguotang Rd.
Tangxia Town
Dongguan,  CN 523000
Applicant Contact Stephen Prior
Correspondent
Medical Devices Pathway, LLC
14330 178th Ln. NE
Woodinville,  WA  98072
Correspondent Contact Caitlyn Dzhafarov
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/04/2025
Decision Date 05/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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