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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 K142470
Device Name E-Shield Multi-paried Subdermal Needle Electrodes
Applicant
Neuroinvent, Inc.
19925 Stevens Creek Blvd., Suite 100
Cupertino,  CA  95014
Applicant Contact CHAO SHENT-CHAO
Correspondent
Neuroinvent, Inc.
19925 Stevens Creek Blvd., Suite 100
Cupertino,  CA  95014
Correspondent Contact CHAO SHENT-CHAO
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received09/03/2014
Decision Date 11/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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