FDA 510(k) Application Details - K143583

Device Classification Name	Filter, Infusion Line   More FDA Info for this Device
510(K) Number	K143583
Device Name	Filter, Infusion Line
Applicant	MERCK MILLIPORE LTD. TULLAGREEN CARRIGTWOHILL EI IE Other 510(k) Applications for this Company
Contact	CHRIS PARR Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2014
Decision Date	08/11/2015
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	N
Expedited Review