BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇮🇳 India

    Cornisol

    K Number: K221759 · Decision Oct 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    20
    Applicant Total
    4
    Review Days
    110

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    Basic Information

    Device Name
    Cornisol
    K Number
    K221759
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aurolab
    Date Received
    June 17, 2022
    Decision Date
    October 5, 2022
    Product Code
    LYX
    Advisory Committee
    Unknown
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYX Media, Corneal Storage

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