FDA 510(k) Application Details - K092075

Device Classification Name Catheter, Percutaneous

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510(K) Number K092075
Device Name Catheter, Percutaneous
Applicant ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 VALLEY VIEW CT.
SYLMAR, CA 91342 US
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Contact COLLEEN CANAN
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 07/09/2009
Decision Date 08/07/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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