510(k) K161613 ยท LGZ Warmer, Thermal, Infusion Fluid
Hang&Go PAC
| Applicant | Rand S.R.L., Medolla, IT |
| Decision | Substantially Equivalent, Dec 28, 2016 |
| Received | Jun 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2021 | RanD S.r.l. Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120 Terminated |
LGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.