FDA 510(k) Applications Submitted by ASAHI MEDICAL CO., LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K970650 02/20/1997 ASAHI AM-R SERIES DIALYZERS ASAHI MEDICAL CO., LTD.
K001250 04/19/2000 APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) ASAHI MEDICAL CO., LTD.
K991512 04/30/1999 ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X ASAHI MEDICAL CO., LTD.
K041726 06/25/2004 HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX ASAHI MEDICAL CO., LTD.
K983720 10/21/1998 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- ASAHI MEDICAL CO., LTD.


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