MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME— 510(k) K032978

Substantially Equivalent

Ciba Vision Corporation

FDA 510(k) clearance K032978 for MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME, Substantially Equivalent on 2003-10-20. Applicant: Ciba Vision Corporation.

Clearance details

Applicant: Ciba Vision Corporation
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 2003-09-24
Decision date: 2003-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Duluth, GA, US

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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.