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Fibra Sonics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K993046FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000November 22, 1999
K984199EXONIXFebruary 17, 1999
K984143FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEMFebruary 16, 1999
K983199FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODELDecember 14, 1998
K980930FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTASeptember 22, 1998
K842024ULTRASONIC LITHOTRIPTOR 300ADecember 11, 1984
K834453PHACO FRAGMENTOR GT-1March 16, 1984
K813389ULTRASONIC FRAGMENTORFebruary 4, 1982
K812909HYGIENTIST; CYCLOSON I & II; RETROFITDecember 14, 1981
K802381LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.December 17, 1980