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

    METAL-BACKED ACETABULAR CUP

    K Number: K831479 · Decision Jun 15, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    175
    Registration Numbers
    175
    Same Product Code
    192
    Applicant Total
    31
    Review Days
    37

    Basic Information

    Device Name
    METAL-BACKED ACETABULAR CUP
    K Number
    K831479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
    Date Received
    May 9, 1983
    Decision Date
    June 15, 1983
    Product Code
    DXQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXQ Blood Pressure Cuff

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