FDA 510(k) Application Details - K050103

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K050103
Device Name	Catheter, Biliary, Diagnostic
Applicant	ABBOTT LABORATORIES 400 SAGINAW DR. REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	ANN E LEONARD 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	01/18/2005
Decision Date	02/16/2005
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