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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, eye movement
510(k) Number K033949
Device Name VARILUX VISIONPRINT SYSTEM (VPS)
Applicant
ESSILOR INTL.
1301 K STREET, NW
WASHINGTON,  DC  20005
Applicant Contact MARC J SCHEINESON
Correspondent
ESSILOR INTL.
1301 K STREET, NW
WASHINGTON,  DC  20005
Correspondent Contact MARC J SCHEINESON
Regulation Number886.1510
Classification Product Code
HLL  
Date Received12/19/2003
Decision Date 07/02/2004
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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