510(k) K180545 ยท FMI Needle, Hypodermic, Single Lumen
VACUETTE SAFELINK Holder with male luer lock
| Applicant | Greiner Bio-One Na, Inc., Monroe NC, US |
| Decision | Substantially Equivalent, May 21, 2018 |
| Received | Mar 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2025 | Greiner Bio-One GmbH VACUETTE SAFELINK, REF: 450210 Open, Classified |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.