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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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More FDA Info for this Product Code
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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