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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perimeter, Automatic, Ac-Powered
510(k) Number K063310
Device Name TRUEFIELD ANALYZER
Applicant
Seeing Machines Limited
11440 W. Bernardo Ct.
Suite 300
San Diego,  CA  92127
Applicant Contact ALAN DONALD
Correspondent
Seeing Machines Limited
11440 W. Bernardo Ct.
Suite 300
San Diego,  CA  92127
Correspondent Contact ALAN DONALD
Regulation Number886.1605
Classification Product Code
HPT  
Date Received11/02/2006
Decision Date 08/02/2007
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
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