510(k) K191057 ยท HRS Plate, Fixation, Bone
Park's Pectus System
| Applicant | Tdm Co., Ltd., Gwangju, KR |
| Decision | Substantially Equivalent, Mar 19, 2020 |
| Received | Apr 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191057
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.