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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K823831
Device Name MEDTRONIC MODELS 59401 5941
Applicant
Medtronic Vascular
Mounds View,  MN  55112
Applicant Contact RACHEL BRUCKER
Correspondent
Medtronic Vascular
Mounds View,  MN  55112
Correspondent Contact RACHEL BRUCKER
Regulation Number870.3610
Classification Product Code
DXY  
Date Received12/21/1982
Decision Date 03/16/1983
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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