K831836 is an FDA 510(k) clearance for the EPSILON ULTRASONIC TIP. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on June 30, 1983, 23 days after receiving the submission on June 7, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K831836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1983 |
| Decision Date | June 30, 1983 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |