RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330— 510(k) K904210

Name: FDA 510(k) clearance K904210
Creator: U.S. Food and Drug Administration
Published: 1990-11-27

Substantially Equivalent

Minntech Corp.

FDA 510(k) clearance K904210 for RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330, Substantially Equivalent on 1990-11-27. Applicant: Minntech Corp.. Device class: 2.

Clearance details

Applicant: Minntech Corp.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1990-09-12
Decision date: 1990-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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