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

    MEDICOOL, CONTAINER FOR STORING INSULIN

    K Number: K895674 · Decision Jan 11, 1990
    View on FDA
    Classifications
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    113

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    Basic Information

    Device Name
    MEDICOOL, CONTAINER FOR STORING INSULIN
    K Number
    K895674
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Medicool, Inc.
    Date Received
    September 20, 1989
    Decision Date
    January 11, 1990
    Product Code
    LDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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