510(k) K190875 ยท HQC Unit, Phacofragmentation
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
| Applicant | D.O.R.C. Dutch Ophthalmic Research Center (International), Zuidland, NL |
| Decision | Substantially Equivalent, Sep 25, 2019 |
| Received | Apr 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2019 | Dutch Ophthalmic USA, Inc. The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201. Open, Classified |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.