510(k) K243149 ยท QLY Ophthalmic Syringe
Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
| Applicant | Congruence Medical Solutions, LLC, Baltimore MD, US |
| Decision | Substantially Equivalent, Dec 20, 2024 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243149
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.