510(k) K011757 ยท FMI Needle, Hypodermic, Single Lumen
EXEL COMFORTPOINT INSULIN PEN NEEDLE
| Applicant | Exelint Intl. Co., Culver City CA, US |
| Decision | Substantially Equivalent, Jan 23, 2002 |
| Received | Jun 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011757
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.