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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixation, Vision Training, Binocular
510(k) Number K051684
Device Name EYEPORT VISION TRAINING SYSTEM
Applicant
Exercise Your Eyes, Inc.
133 Ka Dr.
Kula,  HI  96790
Applicant Contact JACOB LIBERMAN
Correspondent
Exercise Your Eyes, Inc.
133 Ka Dr.
Kula,  HI  96790
Correspondent Contact JACOB LIBERMAN
Regulation Number886.1290
Classification Product Code
NXR  
Date Received06/23/2005
Decision Date 03/17/2006
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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