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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 WEST BERNARDO CT.
SUITE 300
SAN DIEGO,  CA  92127 -1644
Applicant Contact ALAN DONALD
Correspondent
SEEING MACHINES LIMITED
11440 WEST BERNARDO CT.
SUITE 300
SAN DIEGO,  CA  92127 -1644
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
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