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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
510(k) Number K122090
Device Name SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
Applicant
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 VALLEY VIEW CT.
SYLMAR,  CA  91342
Applicant Contact PLESSY PAUL
Correspondent
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 VALLEY VIEW CT.
SYLMAR,  CA  91342
Correspondent Contact PLESSY PAUL
Regulation Number870.2800
Classification Product Code
MXC  
Subsequent Product Codes
DSH   DXH  
Date Received07/16/2012
Decision Date 11/15/2012
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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