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

    FRENZEL EYEGLASSES & RELATED ITEMS

    K Number: K822179 · Decision Sep 21, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    6
    Applicant Total
    94
    Review Days
    60

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    Basic Information

    Device Name
    FRENZEL EYEGLASSES & RELATED ITEMS
    K Number
    K822179
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.1800
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Kelleher Corp.
    Date Received
    July 23, 1982
    Decision Date
    September 21, 1982
    Product Code
    KHH
    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
    KHH Stimulator, Caloric-Air

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