FDA 510(k) Application Details - K081361

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K081361
Device Name	Set, Administration, Intravascular
Applicant	ICU MEDICAL INC 4455 ATHERTON DRIVE SALT LAKE CITY, UT 84123 US Other 510(k) Applications for this Company
Contact	TRACY BEST Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2008
Decision Date	08/28/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review