510(k) K191961 ยท PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
OrthoGold
| Applicant | Tissue Regeneration Technologies, Woodstock GA, US |
| Decision | Substantially Equivalent, Nov 26, 2019 |
| Received | Jul 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191961
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.