K081877 is an FDA 510(k) clearance for the ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Dutch Ophthalmic Research Center International BV (Zuidland, NL). The FDA issued a Cleared decision on January 5, 2009, 187 days after receiving the submission on July 2, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K081877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2008 |
| Decision Date | January 05, 2009 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |