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

    HYDROCELL NASAL AND SINUS PACKS

    K Number: K954491 · Decision Nov 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    46
    Applicant Total
    87
    Review Days
    49

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    Basic Information

    Device Name
    HYDROCELL NASAL AND SINUS PACKS
    K Number
    K954491
    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
    Smith & Nephew Richards, Inc.
    Date Received
    September 27, 1995
    Decision Date
    November 15, 1995
    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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