510(k) K193375 ยท GEX Powered Laser Surgical Instrument
NeuroBlate System
| Applicant | Monteris Medical,, Plymouth MN, US |
| Decision | Substantially Equivalent, Jan 3, 2020 |
| Received | Dec 5, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193375
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.