FDA 510(k) Application Details - K162216

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K162216
Device Name	Set, I.V. Fluid Transfer
Applicant	LABORATORIOS GRIFOLS, S.A. C/CAN GUASCH, 2 PARETS DEL VALLES, 08150 ES Other 510(k) Applications for this Company
Contact	MARTA DANIELA SERRA DE FORTUNY 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	08/08/2016
Decision Date	10/19/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review