BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SOLOPAK BRAND FILTER NEEDLE W/5 MICRO

    K Number: K841280 · Decision May 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    97
    Applicant Total
    9
    Review Days
    54

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    Basic Information

    Device Name
    SOLOPAK BRAND FILTER NEEDLE W/5 MICRO
    K Number
    K841280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Smith & Nephew, Mpl Division
    Date Received
    March 28, 1984
    Decision Date
    May 21, 1984
    Product Code
    FPB
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FPB Filter, Infusion Line

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