K964774 is an FDA 510(k) clearance for the PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS. This device is classified as a Plug, Punctum.
Submitted by Fci Ophthalmics, Inc. (Marshfield Hills, US). The FDA issued a Cleared decision on December 20, 1996, 59 days after receiving the submission on October 22, 1996.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K964774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1996 |
| Decision Date | December 20, 1996 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | LZU — Plug, Punctum |
| Device Class | — |