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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, Polymethylmethacrylate, Diagnostic
510(k) Number K173944
Device Name Endocular Viewing Lenses and Silicone Ring
Applicant
Phakos
62 Rue Kleber
Montreuil,  FR 93100
Applicant Contact J. D. Webb
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J. D. Webb
Regulation Number886.1385
Classification Product Code
HJK  
Date Received12/26/2017
Decision Date 10/25/2018
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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