FDA 510(k) Application Details - K092318

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K092318
Device Name	Set, I.V. Fluid Transfer
Applicant	BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN RD. MPGR-AL MCGAW PARK, IL 60085 US Other 510(k) Applications for this Company
Contact	VALERIE FOLLOWELL 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	08/04/2009
Decision Date	10/30/2009
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	Y
Expedited Review