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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Corneal Storage
510(k) Number K151061
Device Name Cornea Cold
Applicant
Eurobio
7, Ave. De Scandinavie
Les Ulis,  FR F-91953
Applicant Contact Marie-Claude Amoureux
Correspondent
International Medical
4733 Millrace Lane
Murray,  UT  84107
Correspondent Contact JESSICA BARRETT
Classification Product Code
LYX  
Date Received04/20/2015
Decision Date 08/06/2015
Decision Substantially Equivalent (SESE)
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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