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

    SOFT PLATE CUSHION

    K Number: K813190 · Decision Feb 5, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    81

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    Basic Information

    Device Name
    SOFT PLATE CUSHION
    K Number
    K813190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3540
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Leonard Russo Co.
    Date Received
    November 16, 1981
    Decision Date
    February 5, 1982
    Product Code
    EHS
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EHS Cushion, Denture, Over The Counter

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