FDA 510(k) Application Details - K122952

Device Classification Name	Dialyzer, Capillary, Hollow Fiber   More FDA Info for this Device
510(K) Number	K122952
Device Name	Dialyzer, Capillary, Hollow Fiber
Applicant	NIPRO MEDICAL CORPORATION 6695 RIVER CREST PT SUWANEE, GA 30024 US Other 510(k) Applications for this Company
Contact	CAROLYN GEAORGE 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	09/25/2012
Decision Date	12/04/2013
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