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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K150590
Device Name CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
Applicant
Contamac, Ltd.
Bearwalden Business Park
Saffron Walden,  GB CB11 4JX
Applicant Contact Rob McGregor
Correspondent
Eyereg Consulting, Inc.
474 NE 61st Pl
Hillsboro,  OR  97124
Correspondent Contact Bret Andre
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/09/2015
Decision Date 07/10/2015
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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