510(k) K200926 ยท PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
OrthoGold 100
| Applicant | Tissue Regeneration Technologies, LLC, Woodstock GA, US |
| Decision | Substantially Equivalent, Aug 28, 2020 |
| Received | Apr 7, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200926
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.