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

    GOLDEN THERMAL RHINOPLASTY CAST BANDAGE

    K Number: K801301 · Decision Jun 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    1
    Review Days
    17

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    Basic Information

    Device Name
    GOLDEN THERMAL RHINOPLASTY CAST BANDAGE
    K Number
    K801301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Auric, Inc.
    Date Received
    June 3, 1980
    Decision Date
    June 20, 1980
    Product Code
    ILO
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILO Pack, Hot Or Cold, Water Circulating

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