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FDA 510(k) Application Details - K110693
Device Classification Name
Analyzer, Pacemaker Generator Function, Indirect
More FDA Info for this Device
510(K) Number
K110693
Device Name
Analyzer, Pacemaker Generator Function, Indirect
Applicant
MEDTRONIC, INC.
8200 CORAL SEA STREET
MOUNDS VIEW, MN 55304 US
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Contact
RACHEL U LIBI
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Regulation Number
870.3640
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Classification Product Code
KRE
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More FDA Info for this Product Code
Date Received
03/11/2011
Decision Date
06/08/2011
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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