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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 K122161
Device Name SJM CONFIRM
Applicant
ST. JUDE MEDICAL
701 EAST EVELYN AVENUE
SUNNYVALE,  CA  94086 -6527
Applicant Contact Saket Bhatt
Correspondent
ST. JUDE MEDICAL
701 EAST EVELYN AVENUE
SUNNYVALE,  CA  94086 -6527
Correspondent Contact Saket Bhatt
Regulation Number870.2800
Classification Product Code
MXC  
Date Received07/20/2012
Decision Date 11/28/2012
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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