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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chart, visual acuity
510(k) Number K100095
Device Name CENTRAL VISION ANALYZER MODEL 1000
Applicant
VIMETRICS,LLC.
311 E. BALTIMORE AVE
SUITE 100
MEDIA,  PA  19063
Applicant Contact STEPHEN H H SINCLAIR,MD
Correspondent
VIMETRICS,LLC.
311 E. BALTIMORE AVE
SUITE 100
MEDIA,  PA  19063
Correspondent Contact STEPHEN H H SINCLAIR,MD
Regulation Number886.1150
Classification Product Code
HOX  
Date Received01/13/2010
Decision Date 05/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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