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

    LEAD GLASS SHIELDS

    K Number: K872656 · Decision Jul 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    9

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    Basic Information

    Device Name
    LEAD GLASS SHIELDS
    K Number
    K872656
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Viox Corp.
    Date Received
    July 7, 1987
    Decision Date
    July 16, 1987
    Product Code
    IWR
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IWR Holder, Syringe, Lead

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