RENACLEAR DIALYZER CLEANING SYSTEM— 510(k) K991851

Name: FDA 510(k) clearance K991851
Creator: U.S. Food and Drug Administration
Published: 1999-08-30

Substantially Equivalent

Minntech Corp.

FDA 510(k) clearance K991851 for RENACLEAR DIALYZER CLEANING SYSTEM, Substantially Equivalent on 1999-08-30. 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: 1999-06-01
Decision date: 1999-08-30
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.