K850149 is an FDA 510(k) clearance for the KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on April 15, 1985, 91 days after receiving the submission on January 14, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K850149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1985 |
| Decision Date | April 15, 1985 |
| Days to Decision | 91 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 |