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FDA 510(k) Application Details - K001224
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K001224
Device Name
Catheter, Biliary, Diagnostic
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA, CA 95054-2807 US
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Contact
MARGARET ANDERSON
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
04/17/2000
Decision Date
05/17/2000
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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