Submission Details
| 510(k) Number | K021831 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 04, 2002 |
| Decision Date | July 01, 2002 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
K021831 is an FDA 510(k) clearance for the OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB, a Plug, Punctum, submitted by Lacrimedics, Inc. (Eastsound, US). The FDA issued a Cleared decision on July 1, 2002, 27 days after receiving the submission on June 4, 2002. This device falls under the Ophthalmic review panel.
| 510(k) Number | K021831 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 04, 2002 |
| Decision Date | July 01, 2002 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | LZU — Plug, Punctum |
| Device Class | — |