K833494 is an FDA 510(k) clearance for the CLERZ LUBRICATING/REWETTING SOLUTION. This device is classified as a Tonometer, Ac-powered (Class II - Special Controls, product code HKX).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on January 4, 1984, 89 days after receiving the submission on October 7, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K833494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1983 |
| Decision Date | January 04, 1984 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HKX — Tonometer, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |