510(k) K210131 ยท FYC Gown, Isolation, Surgical
ComfortGuard Surgical Isolation Gown
| Applicant | Gri-Alleset, Inc., Flowery Branch GA, US |
| Decision | Substantially Equivalent, Aug 26, 2021 |
| Received | Jan 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210131
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.