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

    NASAL/EPISTAXIS PACK

    K Number: K113585 · Decision Apr 25, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    45
    Applicant Total
    1
    Review Days
    142

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    Basic Information

    Device Name
    NASAL/EPISTAXIS PACK
    K Number
    K113585
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4780
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cogent Therapeutics, LLC
    Date Received
    December 5, 2011
    Decision Date
    April 25, 2012
    Product Code
    LYA
    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
    LYA Splint, Intranasal Septal

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