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FDA 510(k) Application Details - K000793
Device Classification Name
Catheter, Biliary, Diagnostic
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510(K) Number
K000793
Device Name
Catheter, Biliary, Diagnostic
Applicant
GUIDANT CORP.
26531 YNEZ RD.
TEMECULA, CA 92591-4630 US
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Contact
BYRON LAMBERT
Other 510(k) Applications for this Contact
Regulation Number
876.5010
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Classification Product Code
FGE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/13/2000
Decision Date
04/12/2000
Decision
SESE - SUBST EQUIV
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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