510(k) K172954 ยท FYA Gown, Surgical
Medline Prevention CoolZone Gown
| Applicant | Medline Industries, Inc., Northfield IL, US |
| Decision | Substantially Equivalent, Jun 15, 2018 |
| Received | Sep 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172954
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.