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

    ARISTOSURG 250

    K Number: K800395 · Decision Mar 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    281
    Applicant Total
    1
    Review Days
    20

    Basic Information

    Device Name
    ARISTOSURG 250
    K Number
    K800395
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    HALMON-LOCREN, INC.
    Date Received
    February 26, 1980
    Decision Date
    March 17, 1980
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

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