K041998 is an FDA 510(k) clearance for the PHACO CHOP NEEDLES. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 16, 2004, 21 days after receiving the submission on July 26, 2004.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K041998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2004 |
| Decision Date | August 16, 2004 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |