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510(k) K122161

SJM CONFIRM by St Jude Medical — Product Code MXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2012
Date Received
July 20, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

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