510(k) K021989

SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 by Integra Neurosciences — Product Code LFL

K021989 is an FDA 510(k) premarket notification submitted by Integra Neurosciences for the device "SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3". The FDA issued a decision of Substantially Equivalent on September 13, 2002. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Integra Neurosciences has at least 8 other 510(k) clearances on record.