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510(k) K933680

GAMBRO LUNDIA PRO 200 DIALYZER by Cobe Renal Care, Inc. — Product Code FJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1994
Date Received
July 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Parallel Flow
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Cobe Renal Care, Inc.

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  • 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)

Other clearances for product code FJG

  • K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (September 7, 1994)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (March 6, 1992)
  • K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D (August 2, 1990)
  • K902203 — TENCKHOFF PERITONEAL DIALYSIS KIT (August 1, 1990)
  • K862840 — GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (September 29, 1986)
  • K853406 — GAMBRO LUNDIA PRO 3 & 5 DIALYZER (January 8, 1986)
  • K820694 — COBE PPD 1.3L, #18-520-009 (March 31, 1982)
  • K812336 — COBE PPD 1.9 (August 31, 1981)
  • K811440 — EXP 600 PARALLEL PLATE DIALYZER (June 12, 1981)