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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Button, Iris, Eye, Artificial
510(k) Number K001326
Device Name NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
Applicant
Ocular Concepts, LLC
4035 SW Mercantile Dr.
Suite 208
Portland,  OR  97035 -2591
Applicant Contact KEVIN SCHOU
Correspondent
Ocular Concepts, LLC
4035 SW Mercantile Dr.
Suite 208
Portland,  OR  97035 -2591
Correspondent Contact KEVIN SCHOU
Regulation Number886.3200
Classification Product Code
NCK  
Date Received04/26/2000
Decision Date 06/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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