FDA 510(k) Application Details - K990854

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K990854
Device Name	Catheter, Biliary, Diagnostic
Applicant	INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	RICK GAYKOWSKI 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	03/15/1999
Decision Date	08/02/1999
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