510(k) K101593 ยท FYA Gown, Surgical
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
| Applicant | Exact Medical Manufacturing, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Sep 3, 2010 |
| Received | Jun 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101593
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.