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510(k) K880459

480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE by Cd Medical, Inc. — Product Code FKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1988
Date Received
February 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Cd Medical, Inc.

  • K925654 — CD HOME DIALYSERVICE HEMODIALYSIS TRAY (March 30, 1994)
  • K910215 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST (April 9, 1991)
  • K901520 — WURTZ CHOLEY CLIP (TM) (June 26, 1990)
  • K894106 — DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST (November 8, 1989)
  • K884353 — ULTRX(TM) 850 ARTIFICIAL KIDNEY (December 8, 1988)
  • K873279 — 8810 PUMP-PUMP SINGLE NEEDLE DEVICE (October 23, 1987)
  • K864784 — SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS (January 20, 1987)
  • K862304 — DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (September 9, 1986)
  • K853513 — DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY (November 6, 1985)
  • K844185 — MODIFIED C-DAK (January 3, 1985)

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  • K964264 — HIGH RANGE PEROXIDE TEST STRIP (June 16, 1997)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (March 11, 1996)