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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lens, contact (other material) - daily
510(k) Number K180616
Device Name OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
Contamac Ltd.
Carlton House Shire Hall
Saffron Walden,  GB CB11 3AU
Applicant Contact Rob McGregor
EyeReg Consulting, Inc.
6119 Canter Ln
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5916
Classification Product Code
Date Received03/08/2018
Decision Date 04/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No