510(k) K230838 · FYA Gown, Surgical
Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
| Applicant | Cardinal Health200, LLC, Waukegan IL, US |
| Decision | Substantially Equivalent, Jul 27, 2023 |
| Received | Mar 27, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230838
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.