Submission Details
| 510(k) Number | K041998 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
PHACO CHOP NEEDLES
Aug 2004
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K041998 is an FDA 510(k) clearance for the PHACO CHOP NEEDLES, 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 review panel. Regulated under 21 CFR 886.4670.
Device Classification
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4670 |
Manufacturer
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