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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pulse-generator, pacemaker, external
510(k) Number K150246
Device Name Medtronic Model 5392 External Pulse Generator (EPG)
Applicant
Medtronic, Inc
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact Becky Severson
Correspondent
Medtronic, Inc
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact Becky Severson
Regulation Number870.3600
Classification Product Code
DTE  
Date Received02/02/2015
Decision Date 02/18/2015
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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