510(k) K970383 ยท FMI Needle, Hypodermic, Single Lumen
SHARPS CONTAINER
| Applicant | Custom Medical Plastics, Inc., Omaha NE, US |
| Decision | Substantially Equivalent, Jul 3, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970383
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.