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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 K212631
Device Name Optimum Infinite (tisilfocon 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 Lane
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5916
Classification Product Code
HQD  
Subsequent Product Code
MUW  
Date Received08/19/2021
Decision Date 03/17/2022
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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