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

    EYE SURGERY INSTRUMENT

    K Number: K840101 · Decision Mar 16, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    66

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    Basic Information

    Device Name
    EYE SURGERY INSTRUMENT
    K Number
    K840101
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Truline Instruments, Inc.
    Date Received
    January 10, 1984
    Decision Date
    March 16, 1984
    Product Code
    HOB
    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
    HOB Clamp, Muscle, Ophthalmic

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