FDA 510(k) Application Details - K983559

Device Classification Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve   More FDA Info for this Device
510(K) Number	K983559
Device Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant	ICU MEDICAL, INC. 951 CALLE AMANECER SAN CLEMENTE, CA 92673 US Other 510(k) Applications for this Company
Contact	SHERYL SAENZ Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/1998
Decision Date	12/24/1998
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	Y