510(k) K152597 ยท FMI Needle, Hypodermic, Single Lumen
ProteXsure Safety Capsule System
| Applicant | Starcap Medical, LLC ( Dba Prism Medical & Design), Parkland FL, US |
| Decision | Substantially Equivalent, Jun 8, 2016 |
| Received | Sep 11, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152597
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.