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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 K871412
Device Name CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO
Applicant
Contour Electrodes, Inc.
100 S. 13th St.
Herrin,  IL  62948
Applicant Contact KEITH FERRARI
Correspondent
Contour Electrodes, Inc.
100 S. 13th St.
Herrin,  IL  62948
Correspondent Contact KEITH FERRARI
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/08/1987
Decision Date 05/12/1987
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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