FDA 510(k) Application Details - K032926

Device Classification Name Analyzer, Pacemaker Generator Function, Indirect

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510(K) Number K032926
Device Name Analyzer, Pacemaker Generator Function, Indirect
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS, MN 55432-3576 US
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Contact KRISTYN BENSON
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Regulation Number 870.3640

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Classification Product Code KRE
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Date Received 09/22/2003
Decision Date 10/15/2003
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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