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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 K101968
Device Name SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
Applicant
St Jude Medical
701 E.Evelyn Ave.
Sunnyvale,  CA  94086 -6527
Applicant Contact SUSAN ENGELSON
Correspondent
St Jude Medical
701 E.Evelyn Ave.
Sunnyvale,  CA  94086 -6527
Correspondent Contact SUSAN ENGELSON
Regulation Number870.2800
Classification Product Code
MXC  
Date Received07/12/2010
Decision Date 09/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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