BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    CORNEA PERSERVATION UNIT

    K Number: K821170 · Decision Jul 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    20
    Applicant Total
    2
    Review Days
    79

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    Basic Information

    Device Name
    CORNEA PERSERVATION UNIT
    K Number
    K821170
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Xytex Corp.
    Date Received
    April 26, 1982
    Decision Date
    July 14, 1982
    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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    Other Clearances by Xytex Corp.

    K Number Device Name
    K810400 GLYCERINE DEHYDRATION UNIT