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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 K182304
Device Name Hyper GP (tisilfocon A) Daily Wear Contact Lens
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 Received08/24/2018
Decision Date 11/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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