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FDA 510(k) Application Details - K033834
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K033834
Device Name
Catheter, Biliary, Diagnostic
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA, CA 95054 US
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Contact
MICHELLE GROSSMAN
Other 510(k) Applications for this Contact
Regulation Number
876.5010
More FDA Info for this Regulation Number
Classification Product Code
FGE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2003
Decision Date
01/02/2004
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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