Submission Details
| 510(k) Number | K030300 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 29, 2003 |
| Decision Date | May 09, 2003 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
K030300 is an FDA 510(k) clearance for the OPAQUE HERRICK LACRIMAL PLUG, a Plug, Punctum, submitted by Lacrimedics, Inc. (Eastsound, US). The FDA issued a Cleared decision on May 9, 2003, 100 days after receiving the submission on January 29, 2003. This device falls under the Ophthalmic review panel.
| 510(k) Number | K030300 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 29, 2003 |
| Decision Date | May 09, 2003 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU — Plug, Punctum |
| Device Class | — |