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FDA 510(k) Application Details - K051124
Device Classification Name
Catheter, Biliary, Diagnostic
More FDA Info for this Device
510(K) Number
K051124
Device Name
Catheter, Biliary, Diagnostic
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402 US
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Contact
STEPHANIE ROBERTS
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
05/03/2005
Decision Date
07/12/2005
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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