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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 K000637
Device Name CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
Applicant
Alcon Laboratories, Inc.
2800 Discovery Dr.,
Orlando,  FL  32826 -3714
Applicant Contact S.K. MCGARVEY
Correspondent
Alcon Laboratories, Inc.
2800 Discovery Dr.,
Orlando,  FL  32826 -3714
Correspondent Contact S.K. MCGARVEY
Regulation Number886.1760
Classification Product Code
NCF  
Date Received02/25/2000
Decision Date 05/19/2000
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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