510(k) K980930

FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA by Fibra Sonics, Inc. — Product Code LFL

K980930 is an FDA 510(k) premarket notification submitted by Fibra Sonics, Inc. for the device "FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA". The FDA issued a decision of Substantially Equivalent on September 22, 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.