510(k) K111535 ยท FYA Gown, Surgical
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
| Applicant | Exact Medical Manufacturing, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Aug 26, 2011 |
| Received | Jun 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111535
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.