BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS

    K Number: K822272 · Decision Nov 10, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    94
    Review Days
    104

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    Basic Information

    Device Name
    HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS
    K Number
    K822272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4335
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Kelleher Corp.
    Date Received
    July 29, 1982
    Decision Date
    November 10, 1982
    Product Code
    HPQ
    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
    HPQ Headlamp, Operating, Ac-Powered

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