510(k) K851823 ยท FYC Gown, Isolation, Surgical
DISPOSABLE ISOLATION GOWN
| Applicant | American Threshold Industries, Inc., Enka NC, US |
| Decision | Substantially Equivalent, May 17, 1985 |
| Received | Apr 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851823
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.