RAOMER— 510(k) K894112

Substantially Equivalent

Niagara Corp.

FDA 510(k) clearance K894112 for RAOMER, Substantially Equivalent on 1989-07-25. Applicant: Niagara Corp..

Clearance details

Applicant: Niagara Corp.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 1989-06-12
Decision date: 1989-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stanley, NC, US

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Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

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.