GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS— 510(k) K933681

Name: FDA 510(k) clearance K933681
Creator: U.S. Food and Drug Administration
Published: 1994-09-07

Substantially Equivalent

Cobe Renal Care, Inc.

FDA 510(k) clearance K933681 for GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS, Substantially Equivalent on 1994-09-07. 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: 1994-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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