Submission Details
| 510(k) Number | K150288 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 2015 |
| Decision Date | August 28, 2015 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
K150288 is an FDA 510(k) clearance for the PDO Absorbable Punctum Plug, a Plug, Punctum, submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on August 28, 2015, 204 days after receiving the submission on February 5, 2015. This device falls under the Ophthalmic review panel.
| 510(k) Number | K150288 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 2015 |
| Decision Date | August 28, 2015 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU — Plug, Punctum |
| Device Class | — |