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

    THE CHEN MEDIUM

    K Number: K954548 · Decision May 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    231

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    Basic Information

    Device Name
    THE CHEN MEDIUM
    K Number
    K954548
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chen Ophthalmic Laboratories
    Date Received
    October 2, 1995
    Decision Date
    May 20, 1996
    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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