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

    IMAGE DEFLECTOR

    K Number: K833669 · Decision Mar 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    161

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    Basic Information

    Device Name
    IMAGE DEFLECTOR
    K Number
    K833669
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1415
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Michael Onufryk
    Date Received
    October 18, 1983
    Decision Date
    March 27, 1984
    Product Code
    HPA
    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
    HPA Frame, Trial, Ophthalmic

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