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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K983199
Device Name FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
Applicant
Fibra Sonics, Inc.
5312 N. Elston Ave.
Chicago,  IL  60630
Applicant Contact ROBERT BROHM
Correspondent
Fibra Sonics, Inc.
5312 N. Elston Ave.
Chicago,  IL  60630
Correspondent Contact ROBERT BROHM
Classification Product Code
LFL  
Date Received09/14/1998
Decision Date 12/14/1998
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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