510(k) K921058 ยท FYC Gown, Isolation, Surgical
DISPOSABLE ISOLATION GOWN
| Applicant | Nat'L Surtex Corp., Paterson NJ, US |
| Decision | Substantially Equivalent, Aug 11, 1992 |
| Received | Mar 5, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921058
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.