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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 K071118
Device Name GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE
Applicant
Ives Eeg Solutions, Inc.
6325 Rideau Valley Dr.
Manotick, Ontario,  CA K4M 1B3
Applicant Contact JOHN R IVES
Correspondent
Ives Eeg Solutions, Inc.
6325 Rideau Valley Dr.
Manotick, Ontario,  CA K4M 1B3
Correspondent Contact JOHN R IVES
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/20/2007
Decision Date 09/07/2007
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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