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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K890875
Device Name CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
Applicant
Ppg Industries, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Applicant Contact JOHN J TALARICO
Correspondent
Ppg Industries, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Correspondent Contact JOHN J TALARICO
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/21/1989
Decision Date 10/17/1989
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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