Media, Corneal Storage

Device Code: 4436

Product Code(s): LYX

Device Classification Information

Device Type ID4436
Device NameMedia, Corneal Storage
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Intraocular And Corneal Implants Devices Branch (ICIB)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeLYX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4436
DeviceMedia, Corneal Storage
Product CodeLYX
Premarket Reviews
ManufacturerDecision
EUROBIO
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 20:49:06

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