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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K160186
Device Name EnSite Velocity Surface Electrode Kit
Applicant
ST. JUDE MEDICAL
ONE ST. JUDE MEDICAL DRIVE
ST.PAUL,  MN  55117
Applicant Contact YUMI WACKERFUSS
Correspondent
ST. JUDE MEDICAL
ONE ST. JUDE MEDICAL DRIVE
ST.PAUL,  MN  55117
Correspondent Contact YUMI WACKERFUSS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/27/2016
Decision Date 10/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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