510(k) K945223 ยท FYC Gown, Isolation, Surgical
OREX ISOLATION GOWN
| Applicant | Thantex Specialties, Inc., Herndon VA, US |
| Decision | Substantially Equivalent, Apr 25, 1995 |
| Received | Oct 26, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945223
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.