FDA 510(k) Application Details - K082806

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K082806
Device Name	Set, Administration, Intravascular
Applicant	ICU MEDICAL, INC 4455 ATHERTON DR. 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	09/24/2008
Decision Date	04/06/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review