510(k) K921135

IOLAB POWER I.V. POLE by Site Microsurgical Systems, Inc. — Product Code HQC

K921135 is an FDA 510(k) premarket notification submitted by Site Microsurgical Systems, Inc. for the device "IOLAB POWER I.V. POLE". The FDA issued a decision of Substantially Equivalent on June 3, 1992. 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.