FDA 510(k) Application Details - K012347

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K012347
Device Name	Catheter, Biliary, Diagnostic
Applicant	SULZER INTRATHERAPEUTICS, INC. 651 CAMPUS DR. ST. PAUL, MN 55112-3495 US Other 510(k) Applications for this Company
Contact	MARCIA R ELLIS 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	07/24/2001
Decision Date	08/23/2001
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