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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 K950782
Device Name MEDI-TRAC EEG ELECTRODE
Applicant
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1271
Buafflo,  NY  14240
Applicant Contact IGNATY GUSAKOV
Correspondent
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1271
Buafflo,  NY  14240
Correspondent Contact IGNATY GUSAKOV
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/21/1995
Decision Date 06/22/1995
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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