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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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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