510(k) K970547 ยท FMI Needle, Hypodermic, Single Lumen
ISOLYSER SDS SHARPS CONTAINER
| Applicant | Thantex Specialties, Inc., Norcross GA, US |
| Decision | Substantially Equivalent, Jul 18, 1997 |
| Received | Feb 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970547
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.