FDA 510(k) Application Details - K033989

Device Classification Name Catheter, Percutaneous

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510(K) Number K033989
Device Name Catheter, Percutaneous
Applicant MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT
7000 CENTRAL AVE. N.E.
MINNEAPOLIS, MN 55432 US
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Contact KRISTY K MOLLNER
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 12/23/2003
Decision Date 01/22/2004
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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