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

    PosiSep X BAM Hemostat Dressing/Intranasal Splint

    K Number: K220326 · Decision Nov 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    46
    Applicant Total
    10
    Review Days
    283

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    Basic Information

    Device Name
    PosiSep X BAM Hemostat Dressing/Intranasal Splint
    K Number
    K220326
    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
    Hemostasis, LLC
    Date Received
    February 4, 2022
    Decision Date
    November 14, 2022
    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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