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FDA 510(k) Application Details - K082932
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K082932
Device Name
Catheter, Percutaneous
Applicant
ST. JUDE MEDICAL
15900 VALLEY VIEW COURT
SYLMAR,, CA 91342 US
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Contact
COLLEEN CANAN
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2008
Decision Date
12/12/2008
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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