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

    HARRIS CEMENT RESTRICTOR

    K Number: K810353 · Decision Feb 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    36
    Applicant Total
    7
    Review Days
    13

    Basic Information

    Device Name
    HARRIS CEMENT RESTRICTOR
    K Number
    K810353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    CINTOR ORTHOPAEDIC DIV.
    Date Received
    February 10, 1981
    Decision Date
    February 23, 1981
    Product Code
    LZN
    Advisory Committee
    General, Plastic Surgery
    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
    LZN Cement Obturator

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