510(k) K771203 ยท FMI Needle, Hypodermic, Single Lumen
DISP. HYPODERMIC NEEDLE
| Applicant | Terumo America, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 14, 1977 |
| Received | Jul 5, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K771203
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2011 | Terumo Medical Corporation Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.