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FDA 510(k) Application Details - K014205
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K014205
Device Name
Catheter, Biliary, Diagnostic
Applicant
MEDTRONIC AVE, INC.
2170-A NORTHPOINT PRKWY
SANTA ROSA, CA 95407 US
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Contact
KEVIN DRISCO
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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
12/21/2001
Decision Date
01/14/2002
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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