FDA 510(k) Application Details - K023308

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K023308
Device Name	Catheter, Biliary, Diagnostic
Applicant	ORBUS MEDICAL TECHNOLOGIES 5363 N.W. 35TH AVE. FT. LAUDERDALE, FL 33309-6315 US Other 510(k) Applications for this Company
Contact	JIM CLOSSICK 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	10/03/2002
Decision Date	04/14/2003
Decision	SESU - SE - WITH LIMITATIONS
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