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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 K162054
Device Name Medtronic Temporary External Pacemaker 53401
Applicant
MEDTRONIC, INC.
8200 CORAL SEA STREET NE
MOUNDS VIEW,  MN  55112
Applicant Contact SYED SUMRAN MOHIUDDIN
Correspondent
MEDTRONIC, INC.
8200 CORAL SEA STREET NE
MOUNDS VIEW,  MN  55112
Correspondent Contact SYED SUMRAN MOHIUDDIN
Regulation Number870.3600
Classification Product Code
DTE  
Date Received07/25/2016
Decision Date 10/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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