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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aberrometer, Ophthalmic
510(k) Number K023249
Device Name ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
Applicant
Alcon Laboratories, Inc.
2501 Discovery Dr.,
Suite 500
Orlando,  FL  32826 -3714
Applicant Contact CHRISTY STEVENS
Correspondent
Alcon Laboratories, Inc.
2501 Discovery Dr.,
Suite 500
Orlando,  FL  32826 -3714
Correspondent Contact CHRISTY STEVENS
Regulation Number886.1760
Classification Product Code
NCF  
Date Received09/30/2002
Decision Date 10/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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