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510(k) K933680

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

K933680 is an FDA 510(k) premarket notification submitted by Cobe Renal Care, Inc. for the device "GAMBRO LUNDIA PRO 200 DIALYZER". The FDA issued a decision of Substantially Equivalent on August 26, 1994. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Cobe Renal Care, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K955497 — GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET (September 25, 1997)
  • 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)
  • K945746 — GAMBRO LUNDIA 94-500 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)
  • K811439 — EXP 200 PARALLEL PLATE DIALYZER (June 12, 1981)

FDA data resources