510(k) K140026 ยท LZU Plug, Punctum
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
| Applicant | Lacrimedics, Inc., Du Pont WA, US |
| Decision | Substantially Equivalent, Jun 3, 2014 |
| Received | Jan 6, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140026
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2015 | Lacrimedics Inc VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905.
This device is cylindrical in shape, approximately 1.7 Terminated |
LZU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.