510(k) K081877

ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS by Dutch Ophthalmic Research Center International BV — Product Code HQC

K081877 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic Research Center International BV for the device "ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS". The FDA issued a decision of Substantially Equivalent on January 5, 2009. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Dutch Ophthalmic Research Center International BV has at least 3 other 510(k) clearances on record.