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

    KOI DIAMOND KNIFE

    K Number: K812450 · Decision Sep 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    207
    Same Product Code
    53
    Applicant Total
    7
    Review Days
    24

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    Basic Information

    Device Name
    KOI DIAMOND KNIFE
    K Number
    K812450
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Koi, Inc.
    Date Received
    August 28, 1981
    Decision Date
    September 21, 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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