510(k) K191739 ยท GZL Electrode, Depth
Sterile LeadConfirm
| Applicant | Alpha Omega Engineering , Ltd., Nazareth, IL |
| Decision | Substantially Equivalent, Jan 2, 2020 |
| Received | Jun 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191739
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.