510(k) K963830 ยท FMI Needle, Hypodermic, Single Lumen
SHARPS CONTAINER MODEL# SC001
| Applicant | Image Medical, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Sep 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963830
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.