510(k) K050464 ยท FMI Needle, Hypodermic, Single Lumen
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
| Applicant | Ultimed, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 11, 2005 |
| Received | Feb 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050464
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.