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

    EXPANDACEL NASAL TAMPONS, MODIFICATION

    K Number: K912524 · Decision Aug 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    EXPANDACEL NASAL TAMPONS, MODIFICATION
    K Number
    K912524
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4100
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgitrend, Ltd.
    Date Received
    June 3, 1991
    Decision Date
    August 15, 1991
    Product Code
    EMX
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EMX Balloon, Epistaxis

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    Other Clearances by Surgitrend, Ltd.

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    K900171 EXPANDACEL NASAL TAMPONS