510(k) K192362 ยท FYA Gown, Surgical
Aero Blue Performance Surgical Gowns
| Applicant | O&M Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Dec 13, 2019 |
| Received | Aug 30, 2019 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K192362
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2022 | Owens & Minor Distribution, Inc. Aero Blue Performance Surgical Gown, XL- Sterile surgical gown
Code: 41734 Open, Classified |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.