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510(k) K970700

FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX by Fresenius USA, Inc. — Product Code MSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1998
Date Received
February 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialyzer, Re-Use, Low Flux
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Fresenius USA, Inc.

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  • K974584 — FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F80 (May 14, 1998)
  • K973378 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SE (November 3, 1997)
  • K961465 — 2008H ON LINE CLEARANCE MONITOR (July 3, 1997)
  • K961706 — P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL (July 31, 1996)
  • K955762 — PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (July 31, 1996)
  • K941460 — FRESENIUS BLOOD TEMPERATURE MONITOR (July 3, 1996)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (November 29, 1995)
  • K944767 — DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER (November 29, 1995)

Other clearances for product code MSE

  • K001685 — PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 (November 15, 2000)
  • K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BI (May 17, 1999)
  • K974090 — 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS (August 27, 1998)
  • K970661 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) (November 12, 1997)
  • K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (November 12, 1997)
  • K970650 — ASAHI AM-R SERIES DIALYZERS (September 30, 1997)