510(k) K210688 ยท FYA Gown, Surgical
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
| Applicant | O&M Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Jul 21, 2021 |
| Received | Mar 8, 2021 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K210688
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.