FDA 510(k) Application Details - K102721

Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording

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510(K) Number K102721
Device Name Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA, MN 55345-2126 US
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Contact NICOLE BOWDEN
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Regulation Number 870.1220

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Classification Product Code DRF
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Date Received 09/21/2010
Decision Date 10/18/2010
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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