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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K232581
Device Name Medical Disposable Sterile Needle Electrode
Applicant
Suzhou Haishen Medical Device Associates Co., Ltd.
3f, 4f (Rm. 401, 402), 5f, Bldg. 10, # 168
Majian Rd., Suzhou High-Tech Zone
Suzhou,  CN
Applicant Contact Leyi Dai
Correspondent
Sinow Medical AS
Høyteknologisenteret, Thormøhlens Gate 55
Bergen,  NO 5008
Correspondent Contact Jie Gao
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received08/25/2023
Decision Date 12/04/2023
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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