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510(k) K894106

DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST by Cd Medical, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1989
Date Received
June 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
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)
  • 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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