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510(k) K812353

KF-E SERIES OF HOLLOW FIBER DIALYZERS by Medisystems Corp. — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1981
Date Received
August 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Medisystems Corp.

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  • K010279 — MEDISYSTEMS LUER ACCESS INJECTION SITE (May 29, 2001)
  • K002372 — ACCESS ALERT GAUGE (October 25, 2000)
  • K994306 — REVERSO (March 20, 2000)
  • K990803 — MEDISYSTEMS BUTTONHOLE NEEDLE SETS (January 6, 2000)
  • K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR (November 25, 1998)
  • K971860 — MEDISYSTEMS DIALYSIS PRIMING SETS (August 18, 1997)
  • K963668 — MEDISYSTEMS PERITONEAL DIALYSIS SETS (August 15, 1997)
  • K970536 — MEDISYSTEMS TRANDUCER PROTECTOR (May 12, 1997)
  • K953823 — ARTERIAL VENOUS BLOOD TUBING SET (September 23, 1996)

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  • K010366 — DISPOSABLE STORAGE CAP (November 28, 2001)
  • K011148 — ULTRACONCENTRATOR SYSTEM (June 13, 2001)
  • K002761 — FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (December 4, 2000)
  • K991908 — IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (April 17, 2000)
  • K992594 — A-15 HEMODIALYZER (September 24, 1999)
  • K992565 — A-18 HEMODIALYZER (September 23, 1999)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)