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

    OPHTEC RUST RING REMOVER

    K Number: K834354 · Decision Mar 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    4
    Applicant Total
    92
    Review Days
    97

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    Basic Information

    Device Name
    OPHTEC RUST RING REMOVER
    K Number
    K834354
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4070
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Jedmed Instrument Co.
    Date Received
    December 13, 1983
    Decision Date
    March 19, 1984
    Product Code
    HOG
    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
    HOG Burr, Corneal, Battery-Powered

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