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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 K132924
Device Name MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
Applicant
MEDTRONIC, INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact ERIC KALMES
Correspondent
MEDTRONIC, INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact ERIC KALMES
Regulation Number870.3600
Classification Product Code
DTE  
Date Received09/18/2013
Decision Date 10/31/2013
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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