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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 K021566
Device Name INFINITI
Applicant
ALCON LABORATORIES, INC.
6201 SOUTH FREEWAY
FORT WORTH,  TX  76134 -2099
Applicant Contact MICHAEL BUENGER
Correspondent
ALCON LABORATORIES, INC.
6201 SOUTH FREEWAY
FORT WORTH,  TX  76134 -2099
Correspondent Contact MICHAEL BUENGER
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HQR   MLZ  
Date Received05/13/2002
Decision Date 07/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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