The following data is part of a premarket notification filed by Eurobio with the FDA for Cornea Cold.
| Device ID | K151061 |
| 510k Number | K151061 |
| Device Name: | Cornea Cold |
| Classification | Media, Corneal Storage |
| Applicant | EUROBIO 7, AVENUE DE SCANDINAVIE Les Ulis, FR F-91953 |
| Contact | Marie-claude Amoureux |
| Correspondent | Jessica Barrett INTERNATIONAL MEDICAL 4733 MILLRACE LANE Murray, UT 84107 |
| Product Code | LYX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-08-06 |
| Summary: | summary |