FDA 510(k) Application Details - K140402

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K140402
Device Name	Set, I.V. Fluid Transfer
Applicant	MEDSOURCE INTERNATIONAL, LLC. 5346 SHORELINE DR. MOUND, MN 55364 US Other 510(k) Applications for this Company
Contact	JENNIFER NESS 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	02/18/2014
Decision Date	04/03/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review