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

    ISODYNE

    K Number: K770558 · Decision Apr 5, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    ISODYNE
    K Number
    K770558
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Hmw Industries
    Date Received
    March 22, 1977
    Decision Date
    April 5, 1977
    Product Code
    ECO
    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
    ECO Spring, Orthodontic

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