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510(k) K925654

CD HOME DIALYSERVICE HEMODIALYSIS TRAY by Cd Medical, Inc. — Product Code KOC

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 30, 1994
Date Received
November 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Cd Medical, Inc.

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  • K894106 — DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST (November 8, 1989)
  • K884353 — ULTRX(TM) 850 ARTIFICIAL KIDNEY (December 8, 1988)
  • K880459 — 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE (April 13, 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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