510(k) K063450 ยท FMI Needle, Hypodermic, Single Lumen
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110
| Applicant | Smiths Medical Asd, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Jan 25, 2007 |
| Received | Nov 15, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K063450
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.