K946357 is an FDA 510(k) clearance for the COLLAGEN INTRACANALICULAR PLUG. This device is classified as a Plug, Punctum.
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on February 7, 1995, 39 days after receiving the submission on December 30, 1994.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K946357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1994 |
| Decision Date | February 07, 1995 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | LZU — Plug, Punctum |
| Device Class | — |