510(k) K201936 ยท KPE Container, I.V.
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
| Applicant | Gilero, LLC, Morrisville NC, US |
| Decision | Substantially Equivalent, May 6, 2021 |
| Received | Jul 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201936
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.