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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name grid, amsler
510(k) Number K143211
Device Name myVision Track Model 005
Applicant
VITAL ART AND SCIENCE INCORPORATED
2725 N. SPRING DR.
richardson,  TX  75082
Applicant Contact michael bartlett
Correspondent
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
north reading,  MA  01864
Correspondent Contact maureen o'connell
Regulation Number886.1330
Classification Product Code
HOQ  
Date Received11/10/2014
Decision Date 03/20/2015
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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