K243149
- 510(k) number
- K243149
- Device name
- Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
- Applicant
- Congruence Medical Solutions, LLC MD · US
- Product code
- QLY — Ophthalmic Syringe
- Decision date
- 2024-12-20
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243149.pdf
Official FDA record: K243149
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.