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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 K893245
Device Name L30-LB- INFANT LIMB BAND
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 Number870.2360
Classification Product Code
DRX  
Date Received04/28/1989
Decision Date 06/20/1989
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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