CLEARFLUX DIALYZER REPROCESSING SYSTEM— 510(k) K091360

Name: FDA 510(k) clearance K091360
Creator: U.S. Food and Drug Administration
Published: 2010-11-03

Substantially Equivalent

Novaflux Technologies

FDA 510(k) clearance K091360 for CLEARFLUX DIALYZER REPROCESSING SYSTEM, Substantially Equivalent on 2010-11-03. Applicant: Novaflux Technologies. Device class: 2.

Clearance details

Applicant: Novaflux Technologies
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2009-05-08
Decision date: 2010-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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