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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K984143
Device Name FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
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
Regulation Number886.4670
Classification Product Code
HQC  
Date Received11/18/1998
Decision Date 02/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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