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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K945479
Device Name MEDI-TRACE(R) 500 ECG ELECTRODE
Applicant
Graphic Controls Corp.
P.O. Box 1274
189 Van Rensselaer St.
Buffalo,  NY  14240
Applicant Contact IGNATY GUSAKOV
Correspondent
Graphic Controls Corp.
P.O. Box 1274
189 Van Rensselaer St.
Buffalo,  NY  14240
Correspondent Contact IGNATY GUSAKOV
Regulation Number870.2360
Classification Product Code
DRX  
Date Received11/08/1994
Decision Date 07/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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