510(k) K120045 ยท FYA Gown, Surgical
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
| Applicant | Exact Medical Manufacturing, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Jun 12, 2012 |
| Received | Jan 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120045
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.