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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K953996
Device Name NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS
Applicant
NIKKISO CO., LTD.
4503 Moorland Ave.
Minneapolis,  MN  55435
Applicant Contact JEFFERY R SHIDERMAN
Correspondent
NIKKISO CO., LTD.
4503 Moorland Ave.
Minneapolis,  MN  55435
Correspondent Contact JEFFERY R SHIDERMAN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/24/1995
Decision Date 03/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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