FDA 510(k) Application Details - K090917

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K090917
Device Name	Set, I.V. Fluid Transfer
Applicant	BAXA CORP. 14445 GRASSLANDS DR. ENGLEWOOD, CO 80112-7062 US Other 510(k) Applications for this Company
Contact	JIM MORGAN Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2009
Decision Date	02/19/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review