510(k) K200522 ยท FYA Gown, Surgical
AERO CHROME* Breathable Performance Surgical Gowns
| Applicant | O&M Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Mar 16, 2020 |
| Received | Mar 2, 2020 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K200522
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.