RENALIN COLD STERILANT— 510(k) K882564

Substantially Equivalent

Minntech Corp.

FDA 510(k) clearance K882564 for RENALIN COLD STERILANT, Substantially Equivalent on 1989-01-09. Applicant: Minntech Corp..

Clearance details

Applicant: Minntech Corp.
Product code: Code LRJ
Advisory panel: General Hospital
Date received: 1988-06-21
Decision date: 1989-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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.