510(k) K162442 ยท FYA Gown, Surgical
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
| Applicant | Gri Medical & Electrical Technology Co., Ltd., Jiaxing, CN |
| Decision | Substantially Equivalent, Dec 12, 2016 |
| Received | Aug 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162442
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.