510(k) K971487 ยท FMI Needle, Hypodermic, Single Lumen
BKMI DISPOSABLE SYRINGE
| Applicant | Sumi Salud C.A., Front Royal VA, US |
| Decision | Substantially Equivalent, Sep 4, 1997 |
| Received | Apr 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971487
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.