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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name permanent pacemaker electrode
510(k) Number K883743
Device Name MEDTRONIC MODEL 4058 PACING LEAD
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Applicant Contact JENNIFER M MARRONE
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Correspondent Contact JENNIFER M MARRONE
Regulation Number870.3680
Classification Product Code
DTB  
Date Received09/01/1988
Decision Date 01/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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