Submission Details
| 510(k) Number | K820526 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 1982 |
| Decision Date | March 25, 1982 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K820526 is an FDA 510(k) clearance for the RELIEF VALVE-HONAN INTRAOC. PRESSURE, a Applicator, Ocular Pressure (Class II — Special Controls, product code LCC), submitted by The Lebanon Corp. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1982, 27 days after receiving the submission on February 26, 1982. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4610.
| 510(k) Number | K820526 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 1982 |
| Decision Date | March 25, 1982 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | LCC — Applicator, Ocular Pressure |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4610 |