FDA 510(k) Application Details - K010107

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K010107
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	ROBERT FRECHETTE 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	01/12/2001
Decision Date	07/31/2001
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