FDA 510(k) Application Details - K180615

Device Classification Name	Separator, Automated, Blood Cell And Plasma, Therapeutic   More FDA Info for this Device
510(K) Number	K180615
Device Name	Separator, Automated, Blood Cell And Plasma, Therapeutic
Applicant	Fresenius Kabi USA LLC Three Corporate Drive Lake Zurich, IL 60047 US Other 510(k) Applications for this Company
Contact	Kim Forch Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2018
Decision Date	12/04/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review