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

    ADJUSTABLE MICROSURGICAL KNIFE

    K Number: K812620 · Decision Oct 19, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    207
    Same Product Code
    53
    Applicant Total
    10
    Review Days
    34

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    Basic Information

    Device Name
    ADJUSTABLE MICROSURGICAL KNIFE
    K Number
    K812620
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Vxtra Corp.
    Date Received
    September 15, 1981
    Decision Date
    October 19, 1981
    Product Code
    HNN
    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
    HNN Knife, Ophthalmic

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