510(k) K983199

FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL by Fibra Sonics, Inc. — Product Code LFL

K983199 is an FDA 510(k) premarket notification submitted by Fibra Sonics, Inc. for the device "FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL". The FDA issued a decision of Substantially Equivalent on December 14, 1998. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Fibra Sonics, Inc. has at least 9 other 510(k) clearances on record.