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

    EAR KNIVES

    K Number: K840764 · Decision May 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    6
    Applicant Total
    9
    Review Days
    88

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    Basic Information

    Device Name
    EAR KNIVES
    K Number
    K840764
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Sharpoint, Inc.
    Date Received
    February 23, 1984
    Decision Date
    May 21, 1984
    Product Code
    JYO
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JYO Knife, Ear

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