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510(k) K873279

8810 PUMP-PUMP SINGLE NEEDLE DEVICE by Cd Medical, Inc. — Product Code FIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1987
Date Received
August 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Dialysis, Single Needle With Uni-Directional Pump
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K884353 — ULTRX(TM) 850 ARTIFICIAL KIDNEY (December 8, 1988)
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  • 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)

Other clearances for product code FIF

  • K820173 — COBE SINGLE-NEEDLE CONTROLLER #18-756 (March 23, 1982)
  • K802230 — BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP (December 22, 1980)
  • K801967 — MEDCOMP FEMORAL VEIN CATHETER (September 26, 1980)
  • K792174 — MODEL DM 353 & DM-353-L SINGLE NEEDLE (November 16, 1979)
  • K772147 — GW 35 GUIDE WIRE (November 28, 1977)