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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 K960968
Device Name MEDI-TRACE 200, MEDI-TRACE 200-30
Applicant
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
P.O. BOX 1271
BUAFFLO,  NY  14240 -1271
Applicant Contact KATHLEEN SELOVER
Correspondent
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
P.O. BOX 1271
BUAFFLO,  NY  14240 -1271
Correspondent Contact KATHLEEN SELOVER
Regulation Number870.2360
Classification Product Code
DRX  
Date Received03/11/1996
Decision Date 10/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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