510(k) K190610 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
| Applicant | Sterilmed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 15, 2019 |
| Received | Mar 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190610
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.