Submission Details
| 510(k) Number | K963501 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 03, 1996 |
| Decision Date | April 14, 1997 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
K963501 is an FDA 510(k) clearance for the HERRICK ULTIMATE PUNCTUM PLUG, a Plug, Punctum, submitted by Lacrimedics, Inc. (Rialto, US). The FDA issued a Cleared decision on April 14, 1997, 223 days after receiving the submission on September 3, 1996. This device falls under the Ophthalmic review panel.
| 510(k) Number | K963501 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 03, 1996 |
| Decision Date | April 14, 1997 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU — Plug, Punctum |
| Device Class | — |