K832074 is an FDA 510(k) clearance for the CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA. This device is classified as a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II - Special Controls, product code HKP).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on August 1, 1983, 34 days after receiving the submission on June 28, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K832074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 1983 |
| Decision Date | August 01, 1983 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HKP — Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |