510(k) K911037 ยท FMI Needle, Hypodermic, Single Lumen
SAFETY NEEDLE SHEATH, MODIFICATION
| Applicant | Concord/Portex, Keene NH, US |
| Decision | Substantially Equivalent, May 3, 1991 |
| Received | Mar 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911037
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.