K231106
- 510(k) number
- K231106
- Device name
- Accuject Refra Injector AR2900
- Applicant
- Medicel AG CH
- Product code
- MSS — Folders And Injectors, Intraocular Lens (Iol)
- Decision date
- 2023-09-19
- Date received
- 2023-04-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K231106.pdf
Official FDA record: K231106
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.