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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K955597
Device Name MEDI-TRACE DEFIB PADS
Applicant
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1271
Buafflo,  NY  14240
Applicant Contact SUSAN KRASNY
Correspondent
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1271
Buafflo,  NY  14240
Correspondent Contact SUSAN KRASNY
Regulation Number882.1275
Classification Product Code
GYB  
Date Received12/08/1995
Decision Date 07/09/1996
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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