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510(k) K955497

GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET by Cobe Renal Care, Inc. — Product Code KDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1997
Date Received
December 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Perfusion, Kidney, Disposable
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances by Cobe Renal Care, Inc.

  • K955592 — COBE CENTRYSYSTEM 14 PES HEMODIALYZERS (April 30, 1997)
  • K955487 — GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS (April 18, 1997)
  • K946279 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (February 10, 1997)
  • K954003 — COBE HEMODYNAMIC RECIRCULATION MONITOR (February 6, 1997)
  • K960474 — COBE CENTRYSYSTEM 600 HG HEMODIALYZERS (August 14, 1996)
  • K944436 — COBE CENTRYSYSTEM CS 200 DIALYZER (January 29, 1996)
  • K951311 — GAMBRO HC 14R HEMOCONCENTRATOR (January 11, 1996)
  • K952342 — GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS (September 15, 1995)
  • K945747 — GAMBRO LUNDIA 94-600 DIALYZER (September 8, 1995)
  • K945746 — GAMBRO LUNDIA 94-500 DIALYZER (September 8, 1995)

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