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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 K042190
Device Name MODEL 6416 TEMPORARY PACING LEAD SYSTEM
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MAIL STOP T-202
MINNEAPOLIS,  MN  55432 -3576
Applicant Contact PAULA CORDERO
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MAIL STOP T-202
MINNEAPOLIS,  MN  55432 -3576
Correspondent Contact PAULA CORDERO
Regulation Number870.3680
Classification Product Code
LDF  
Date Received08/12/2004
Decision Date 09/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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