510(k) K011925 ยท FMI Needle, Hypodermic, Single Lumen
HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
| Applicant | Sims Portex, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Jul 12, 2001 |
| Received | Jun 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Smiths Medical ASD, Inc. Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2''
Reference Number: 4313 Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.