FDA 510(k) Application Details - K080007

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K080007
Device Name	Catheter, Straight
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	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2008
Decision Date	05/13/2008
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