510(k) K201166 ยท KNW Instrument, Biopsy
Temno Elite Biopsy System
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Aug 28, 2020 |
| Received | May 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201166
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.