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

    MOLDED POLYSULFONE TRIAL PROSTHESIS

    K Number: K811205 · Decision May 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    434
    Registration Numbers
    434
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    20

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    Basic Information

    Device Name
    MOLDED POLYSULFONE TRIAL PROSTHESIS
    K Number
    K811205
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4800
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Shannon Group
    Date Received
    May 1, 1981
    Decision Date
    May 21, 1981
    Product Code
    HWT
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HWT Template

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