K915118 is an FDA 510(k) clearance for the PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE. 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 December 27, 1991, 44 days after receiving the submission on November 13, 1991.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K915118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1991 |
| Decision Date | December 27, 1991 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |