K980437 is an FDA 510(k) clearance for the SILICONE PUNCTAL PLUG. This device is classified as a Plug, Punctum.
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on April 30, 1998, 85 days after receiving the submission on February 4, 1998.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K980437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 1998 |
| Decision Date | April 30, 1998 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU - Plug, Punctum |
| Device Class | - |