K230951
- 510(k) number
- K230951
- Device name
- Terumo Injection Filter Needle (NF-3013RBKE05M)
- Applicant
- Terumo Europe N.V. BE
- Product code
- QYM — Ophthalmic Needle
- Decision date
- 2023-10-18
- Date received
- 2023-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K230951.pdf
Official FDA record: K230951
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.