K864726 is an FDA 510(k) clearance for the I/A/KPE TIP. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on January 20, 1987, 85 days after receiving the submission on October 27, 1986.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K864726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1986 |
| Decision Date | January 20, 1987 |
| Days to Decision | 85 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 |