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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 K171077
Device Name HEXA100 (hexafocon A) Daily Wear Contact Lenses
Applicant
CONTAMAC Ltd.
Carlton House Shire Hill
Saffron Walden,  GB CB11 3AU
Applicant Contact Rob McGregor
Correspondent
EyeReg Consulting, Inc.
6119 Canter Ln
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5916
Classification Product Code
HQD  
Subsequent Product Code
MUW  
Date Received04/11/2017
Decision Date 08/01/2017
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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