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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 K890201
Device Name RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
Applicant
MEDTRONIC VASCULAR
60 NEWARK ST.
HAVERHILL,  MA  01830
Applicant Contact EDWARD SHAUGHNESSY
Correspondent
MEDTRONIC VASCULAR
60 NEWARK ST.
HAVERHILL,  MA  01830
Correspondent Contact EDWARD SHAUGHNESSY
Regulation Number870.2360
Classification Product Code
DRX  
Date Received01/17/1989
Decision Date 03/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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