GAMBRO LUNDIA PRO 200 DIALYZER— 510(k) K933680

Name: FDA 510(k) clearance K933680
Creator: U.S. Food and Drug Administration
Published: 1994-08-26

Substantially Equivalent

Cobe Renal Care, Inc.

FDA 510(k) clearance K933680 for GAMBRO LUNDIA PRO 200 DIALYZER, Substantially Equivalent on 1994-08-26. Applicant: Cobe Renal Care, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Renal Care, Inc.
Product code: Code FJG
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1993-07-29
Decision date: 1994-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FJG

view all

K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS1994-09-07
K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-91992-09-21
K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS1992-03-06
K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D1990-08-02
K902203 — TENCKHOFF PERITONEAL DIALYSIS KIT1990-08-01

More clearances from Cobe Renal Care, Inc.

view all

K955497 — GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET1997-09-25
K955592 — COBE CENTRYSYSTEM 14 PES HEMODIALYZERS1997-04-30
K955487 — GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS1997-04-18
K946279 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)1997-02-10
K954003 — COBE HEMODYNAMIC RECIRCULATION MONITOR1997-02-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.