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

    APDYNE PHENOL APPLICATOR KIT

    K Number: K894369 · Decision Oct 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    APDYNE PHENOL APPLICATOR KIT
    K Number
    K894369
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5220
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Apdyne Medical Co.
    Date Received
    July 14, 1989
    Decision Date
    October 12, 1989
    Product Code
    KCJ
    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
    KCJ Applicator, Ent

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