FDA 510(k) Application Details - K001648

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K001648
Device Name	Catheter, Biliary, Diagnostic
Applicant	INTRATHERAPEUTICS, INC. 651 CAMPUS DR. ST. PAUL, MN 55112 US Other 510(k) Applications for this Company
Contact	CATHY YOHNK 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	05/30/2000
Decision Date	08/28/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review