K253551

Substantially Equivalent

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Applicant: Depuy Ireland UC
Product code: QIH
Advisory panel: Radiology
Date received: 2025-11-14
Decision date: 2026-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringaskiddy, Co. Cork, IE

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Data sourced from openFDA. This site is unofficial and independent of the FDA.