RENALIN COLD STERILANT— 510(k) K941439

Name: FDA 510(k) clearance K941439
Creator: U.S. Food and Drug Administration
Published: 1995-06-26

Substantially Equivalent

Minntech Corp.

FDA 510(k) clearance K941439 for RENALIN COLD STERILANT, Substantially Equivalent on 1995-06-26. Applicant: Minntech Corp.. Device class: 1.

Clearance details

Applicant: Minntech Corp.
Product code: Code LRJ
Device class: Class 1
Regulation: 21 CFR 880.6890
Advisory panel: General Hospital
Date received: 1994-03-24
Decision date: 1995-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRJ

product code LRJ

Injury: 958
Total: 958

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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