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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, pacemaker, temporary
510(k) Number K012452
Device Name MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MS CW304
MINNEAPOLIS,  MN  55432 -3576
Applicant Contact TINA BENOIT
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MS CW304
MINNEAPOLIS,  MN  55432 -3576
Correspondent Contact TINA BENOIT
Regulation Number870.3680
Classification Product Code
LDF  
Date Received08/01/2001
Decision Date 08/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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