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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 K940703
Device Name MEDTRONIC MODEL 4558M
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS,  MN  55432 -3576
Applicant Contact CHARLES H SWANSON
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS,  MN  55432 -3576
Correspondent Contact CHARLES H SWANSON
Regulation Number870.3680
Classification Product Code
DTB  
Date Received02/16/1994
Decision Date 11/04/1994
Decision SE - Postmarket Surveillance Required (SESP)
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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