510(k) K972410 ยท FYC Gown, Isolation, Surgical
IMPERVIOUS ISOLATION GOWN
| Applicant | Kentron Health Care, Inc., Springfield TN, US |
| Decision | Substantially Equivalent, Sep 19, 1997 |
| Received | Jun 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972410
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.