510(k) K163191 ยท FYA Gown, Surgical
ComfortGuard Surgical Gown, i600, Film Reinforced
| Applicant | Gri Medical & Electrical Technology Co., Ltd., Jiaxing, CN |
| Decision | Substantially Equivalent, Feb 27, 2017 |
| Received | Nov 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163191
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.