GAMBRO LUNDIA ALPHA HEMODIALYZERS— 510(k) K915504

Name: FDA 510(k) clearance K915504
Creator: U.S. Food and Drug Administration
Published: 1992-03-06

Substantially Equivalent

C.G.H. Medical, Inc.

FDA 510(k) clearance K915504 for GAMBRO LUNDIA ALPHA HEMODIALYZERS, Substantially Equivalent on 1992-03-06. Applicant: C.G.H. Medical, Inc.. Device class: 2.

Clearance details

Applicant: C.G.H. Medical, Inc.
Product code: Code FJG
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1991-12-09
Decision date: 1992-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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