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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 K063331
Device Name BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
Applicant
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER,  NY  14609 -3547
Applicant Contact LISA C GRANEY
Correspondent
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER,  NY  14609 -3547
Correspondent Contact LISA C GRANEY
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
HQE  
Date Received11/03/2006
Decision Date 12/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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