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FDA 510(k) Application Details - K160809
Device Classification Name
Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)
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510(K) Number
K160809
Device Name
Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)
Applicant
MEDTRONIC, INC.
8200 CORAL SEA ST NW
MOUNDS VIEW, MN 55112 US
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Contact
Dianna L Johannson
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Regulation Number
870.1025
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Classification Product Code
MXD
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More FDA Info for this Product Code
Date Received
03/24/2016
Decision Date
05/26/2016
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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