Cornea Cold

Media, Corneal Storage

EUROBIO

The following data is part of a premarket notification filed by Eurobio with the FDA for Cornea Cold.

Pre-market Notification Details

Device IDK151061
510k NumberK151061
Device Name:Cornea Cold
ClassificationMedia, Corneal Storage
Applicant EUROBIO 7, AVENUE DE SCANDINAVIE Les Ulis,  FR F-91953
ContactMarie-claude Amoureux
CorrespondentJessica Barrett
INTERNATIONAL MEDICAL 4733 MILLRACE LANE Murray,  UT  84107
Product CodeLYX  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-20
Decision Date2015-08-06
Summary:summary

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