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

    NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER

    K Number: K140542 · Decision Jun 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    115

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    Basic Information

    Device Name
    NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER
    K Number
    K140542
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5550
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rhinosystems, Inc.
    Date Received
    March 4, 2014
    Decision Date
    June 27, 2014
    Product Code
    KMA
    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
    KMA Irrigator, Powered Nasal

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