510(k) K192310 ยท GXR Cover, Burr Hole
Flap Fixator, Burr Hole Cover
| Applicant | Ossaware Biotech Co., Ltd., Shenkang Hsiang, TW |
| Decision | Substantially Equivalent, Jun 3, 2020 |
| Received | Aug 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192310
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.