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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 K901555
Device Name MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
Applicant
MEDTRONIC VASCULAR
60 NEWARK ST.
HAVERHILL,  MA  01830
Applicant Contact JANICE M PEVIDE
Correspondent
MEDTRONIC VASCULAR
60 NEWARK ST.
HAVERHILL,  MA  01830
Correspondent Contact JANICE M PEVIDE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/03/1990
Decision Date 07/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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