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FDA 510(k) Application Details - K011506
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K011506
Device Name
Catheter, Biliary, Diagnostic
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA, CA 95054-2807 US
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Contact
CURTIS TRUESDALE
Other 510(k) Applications for this Contact
Regulation Number
876.5010
More FDA Info for this Regulation Number
Classification Product Code
FGE
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More FDA Info for this Product Code
Date Received
05/16/2001
Decision Date
06/15/2001
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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