510(k) K113186 ยท FMI Needle, Hypodermic, Single Lumen
STERILE INSULIN PEN NEEDLE
| Applicant | Shina Corp., Chungchengnam-Do, KR |
| Decision | Substantially Equivalent, Apr 12, 2012 |
| Received | Oct 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113186
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.