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FDA 510(k) Application Details - K081365
Device Classification Name
Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
More FDA Info for this Device
510(K) Number
K081365
Device Name
Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
Applicant
ST. JUDE MEDICAL
701 EAST EVELYN AVENUE
SUNNYVALE, CA 94086-6527 US
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Contact
ELIZABETH E NEELY
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Regulation Number
870.2800
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Classification Product Code
MXC
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More FDA Info for this Product Code
Date Received
05/15/2008
Decision Date
08/15/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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