510(k) K923630

PHACO NEEDLES 1000-R & 1000-O NEEDLES by O.R. Specialties, Inc. — Product Code HQC

K923630 is an FDA 510(k) premarket notification submitted by O.R. Specialties, Inc. for the device "PHACO NEEDLES 1000-R & 1000-O NEEDLES". The FDA issued a decision of Substantially Equivalent on April 6, 1994. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. O.R. Specialties, Inc. has at least 10 other 510(k) clearances on record.