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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name products, contact lens care, rigid gas permeable
510(k) Number K181566
Device Name Nutrifill
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 Number886.5918
Classification Product Code
MRC  
Date Received06/14/2018
Decision Date 10/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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