510(k) K912739

SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE by Site Microsurgical Systems, Inc. — Product Code HQC

K912739 is an FDA 510(k) premarket notification submitted by Site Microsurgical Systems, Inc. for the device "SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE". The FDA issued a decision of Substantially Equivalent on August 28, 1991. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Site Microsurgical Systems, Inc. has at least 10 other 510(k) clearances on record.