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

    INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17

    K Number: K872607 · Decision Oct 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1189
    Registration Numbers
    1190
    Same Product Code
    197
    Applicant Total
    1
    Review Days
    91

    Basic Information

    Device Name
    INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17
    K Number
    K872607
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5842
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    RANDOLPH ENGINEERING, INC.
    Date Received
    July 6, 1987
    Decision Date
    October 5, 1987
    Product Code
    HQZ
    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
    HQZ Frame, Spectacle

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