510(k) K120395 ยท FPA Set, Administration, Intravascular
NERIA MULTI SUBCUTANEOUS INFUSION SET
| Applicant | Unomedical Devices S.A DE C.V., Reynosa, MX |
| Decision | Substantially Equivalent, May 30, 2012 |
| Received | Feb 8, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2015 | Unomedical As Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset
Used in combination with infusion pumps for continuous subcutaneous infusion of medication. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.