510(k) K983067 ยท FMI Needle, Hypodermic, Single Lumen
FINE-JECT
| Applicant | Henke Sass Wolf of America, Inc., Southbridge MA, US |
| Decision | Substantially Equivalent, Oct 30, 1998 |
| Received | Sep 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983067
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.