510(k) K112796 ยท FYA Gown, Surgical
SURGICAL GOWN (EO STERILIZED)
| Applicant | Cobes Industries Co., Ltd., Dover DE, US |
| Decision | Substantially Equivalent, Sep 12, 2013 |
| Received | Sep 26, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112796
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.