GAMBRO LUNDIA PLATE DISP. DIALYZER— 510(k) K802389

Name: FDA 510(k) clearance K802389
Creator: U.S. Food and Drug Administration
Published: 1980-12-22

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K802389 for GAMBRO LUNDIA PLATE DISP. DIALYZER, Substantially Equivalent on 1980-12-22. Applicant: Gambro, Inc.. Device class: 2.

Clearance details

Applicant: Gambro, Inc.
Product code: Code FJG
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1980-09-29
Decision date: 1980-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS1992-03-06
K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D1990-08-02

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K032431 — PRISMA M60/M100 SETS2003-09-15
K896758 — GAMBRO BICARBONATE MONITOR BCM 10-31990-09-28
K896757 — GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS1990-08-30

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