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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 K863536
Device Name MEDTRONIC MODEL 5013
Applicant
Medtronic Vascular
7000 Central Ave. N.E
Minneapolis,  MN  55432
Applicant Contact EDWARD NUMAINVILLE
Correspondent
Medtronic Vascular
7000 Central Ave. N.E
Minneapolis,  MN  55432
Correspondent Contact EDWARD NUMAINVILLE
Regulation Number870.3680
Classification Product Code
DTB  
Date Received09/11/1986
Decision Date 01/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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