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

    ENTAXIS NASAL PACKING

    K Number: K984069 · Decision Jan 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    46
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    ENTAXIS NASAL PACKING
    K Number
    K984069
    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
    Les Laboratorires Brothier, S.A.
    Date Received
    November 16, 1998
    Decision Date
    January 25, 1999
    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 Les Laboratorires Brothier, S.A.

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    K041446 NASALCEASE
    K922540 WOUND DRESSING
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    K893123 ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES