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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K002869
Device Name LOCALISA CARDIAC NAVIGATION SYSTEM
Original Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
3850 victoria st. north
shoreview,  MN  55126
Original Contact thomas parker
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/13/2000
Decision Date 03/27/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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