FDA 510(k) Applications for Medical Device Product Code: MSE (Hemodialyzer, Re-Use, Low Flux)

FDA 510(k) Applications for Medical Device Product Code "MSE"
(Hemodialyzer, Re-Use, Low Flux)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K983720	ASAHI MEDICAL CO., LTD.	ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-	05/17/1999
K970650	ASAHI MEDICAL CO., LTD.	ASAHI AM-R SERIES DIALYZERS	09/30/1997
K970661	BAXTER HEALTHCARE CORP.	CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)	11/12/1997
K970654	BAXTER HEALTHCARE CORP.	CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)	11/12/1997
K001685	BAXTER HEALTHCARE CORP.	PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210	11/15/2000
K974090	FRESENIUS MEDICAL CARE NORTH AMERICA	95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS	08/27/1998
K970700	FRESENIUS USA, INC.	FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX	09/15/1998