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

    LIFE4C

    K Number: K063304 · Decision Dec 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    415

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    Basic Information

    Device Name
    LIFE4C
    K Number
    K063304
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Numedis, Inc.
    Date Received
    November 1, 2006
    Decision Date
    December 21, 2007
    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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