BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MAGNILINK SYSTEM 402/5

    K Number: K892350 · Decision May 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    14
    Review Days
    51

    Basic Information

    Device Name
    MAGNILINK SYSTEM 402/5
    K Number
    K892350
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5820
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    COBURN OPTICAL IND., INC.
    Date Received
    April 5, 1989
    Decision Date
    May 26, 1989
    Product Code
    HJG
    Advisory Committee
    Ophthalmic
    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
    HJG System, Reading, Television, Closed-Circuit

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    Other Clearances by COBURN OPTICAL IND., INC.

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