510(k) K891677 ยท FYC Gown, Isolation, Surgical
COATED ISOLATION GOWN
| Applicant | Durante Intl., Inc., Houston TX, US |
| Decision | Substantially Equivalent, Apr 20, 1989 |
| Received | Mar 21, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891677
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.