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

    INSU COOL

    K Number: K885055 · Decision Apr 26, 1989
    View on FDA
    Classifications
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    140

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    Basic Information

    Device Name
    INSU COOL
    K Number
    K885055
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Dynex Trading Co.
    Date Received
    December 7, 1988
    Decision Date
    April 26, 1989
    Product Code
    LDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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