510(k) K923127 ยท FMI Needle, Hypodermic, Single Lumen
NEEDLE-PRO CARTRIDGE
| Applicant | Concord/Portex, Keene NH, US |
| Decision | Substantially Equivalent, Apr 29, 1993 |
| Received | Jun 26, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2017 | Smiths Medical ASD Inc. Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO. Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.