LUNDIA PLATE DISPOSABLE DIALYZER— 510(k) K780700

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K780700 for LUNDIA PLATE DISPOSABLE DIALYZER, Substantially Equivalent on 1978-07-17. 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: 1978-04-26
Decision date: 1978-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FJG

K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS1994-09-07
K933680 — GAMBRO LUNDIA PRO 200 DIALYZER1994-08-26
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

More clearances from Gambro, Inc.

K083158 — EXALIS, SOFTWARE VERSION 1.152009-06-05
K070643 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.352007-11-02
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.