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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K854559
Device Name MEDTRONIC PERMANENT LEAD INTRODUCER
Original Applicant
MEDTRONIC VASCULAR
800 53rd avenue, ne
p.o. box 1250
minneapolis,  MN  55440 9087
Original Contact alan marquardt
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/14/1985
Decision Date 12/24/1985
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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