510(k) K955245

MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM by Mentor O & O, Inc. — Product Code HQC

K955245 is an FDA 510(k) premarket notification submitted by Mentor O & O, Inc. for the device "MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 12, 1996. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Mentor O & O, Inc. has at least 10 other 510(k) clearances on record.