510(k) K982058 ยท FYA Gown, Surgical
ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
| Applicant | Encompass Group, LLC, Mcdonough GA, US |
| Decision | Substantially Equivalent, Jan 14, 1999 |
| Received | Jun 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982058
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.