FDA 510(k) Application Details - K983154

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K983154
Device Name	Catheter, Biliary, Diagnostic
Applicant	APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 LAGUNA HILLS, CA 92653 US Other 510(k) Applications for this Company
Contact	HOWARD V ROWE 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	09/09/1998
Decision Date	05/05/1999
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