SILVERSITE OR CALGITROL— 510(k) K041268

Substantially Equivalent

Adri

FDA 510(k) clearance K041268 for SILVERSITE OR CALGITROL, Substantially Equivalent on 2004-09-20. Applicant: Adri.

Clearance details

Applicant: Adri
Product code: Code MGQ
Advisory panel: Unknown
Date received: 2004-05-12
Decision date: 2004-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Forest, IL, US

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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.