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FDA 510(k) Application Details - K101968
Device Classification Name
Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
More FDA Info for this Device
510(K) Number
K101968
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
SUSAN ENGELSON
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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
07/12/2010
Decision Date
09/15/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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