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FDA 510(k) Application Details - K053459
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K053459
Device Name
Catheter, Biliary, Diagnostic
Applicant
GUIDANT CORPORATION
26531 YNEZ ROAD
TEMECULA, CA 92591 US
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Contact
SYLVIA HERNANDEZ
Other 510(k) Applications for this Contact
Regulation Number
876.5010
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Classification Product Code
FGE
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More FDA Info for this Product Code
Date Received
12/13/2005
Decision Date
04/12/2006
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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