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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 K863369
Device Name MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES
Applicant
Tdk Corp.
Masuda/Funai/Eifert/Mitchell
134 N. Lasalle St., 17th Floor
Chicago,  IL  60602
Applicant Contact E SASAMOTO
Correspondent
Tdk Corp.
Masuda/Funai/Eifert/Mitchell
134 N. Lasalle St., 17th Floor
Chicago,  IL  60602
Correspondent Contact E SASAMOTO
Regulation Number870.2360
Classification Product Code
DRX  
Date Received07/24/1986
Decision Date 01/06/1987
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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