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

    SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.

    K Number: K904878 · Decision Mar 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    128

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    Basic Information

    Device Name
    SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
    K Number
    K904878
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Hpi, Inc.
    Date Received
    October 30, 1990
    Decision Date
    March 7, 1991
    Product Code
    IWP
    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
    IWP Radiographic Protective Glove

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