CENTURION SES EPIKERATOME— 510(k) K042810

Substantially Equivalent

Norwood Abbey , Ltd.

FDA 510(k) clearance K042810 for CENTURION SES EPIKERATOME, Substantially Equivalent on 2004-10-28. Applicant: Norwood Abbey , Ltd..

Clearance details

Applicant: Norwood Abbey , Ltd.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 2004-10-12
Decision date: 2004-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Chelsea Hgts., Victoria, AU

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Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

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.