FDA 510(k) Application Details - K040505

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K040505
Device Name	Catheter, Biliary, Diagnostic
Applicant	COOK, INC. 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON, IN 47402 US Other 510(k) Applications for this Company
Contact	LELAND KEYT Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	FGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2004
Decision Date	03/16/2004
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