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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K900682
Device Name PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE
Applicant
Contour Electrodes, Inc.
100 S. 13th St.
Herrin,  IL  62948
Applicant Contact PARIS WALKER
Correspondent
Contour Electrodes, Inc.
100 S. 13th St.
Herrin,  IL  62948
Correspondent Contact PARIS WALKER
Regulation Number870.4330
Classification Product Code
DRY  
Date Received02/13/1990
Decision Date 07/31/1990
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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