FDA 510(k) Application Details - K042190

Device Classification Name Electrode, Pacemaker, Temporary

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510(K) Number K042190
Device Name Electrode, Pacemaker, Temporary
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MAIL STOP T-202
MINNEAPOLIS, MN 55432-3576 US
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Contact PAULA CORDERO
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Regulation Number 870.3680

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Classification Product Code LDF
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Date Received 08/12/2004
Decision Date 09/07/2004
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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