FDA 510(k) Application Details - K190459

Device Classification Name	Dialyzer, Capillary, Hollow Fiber   More FDA Info for this Device
510(K) Number	K190459
Device Name	Dialyzer, Capillary, Hollow Fiber
Applicant	Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Denise Oppermann Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/2019
Decision Date	08/23/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review