510(k) K994197 ยท FMI Needle, Hypodermic, Single Lumen
DISENTRONIC PENFINE INJECTION PEN NEEDLE
| Applicant | Disetronic Medical Systems, Fort Myers FL, US |
| Decision | Substantially Equivalent, Dec 29, 1999 |
| Received | Dec 13, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K994197
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.