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

    PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)

    K Number: K954331 · Decision Jan 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    97
    Applicant Total
    28
    Review Days
    482

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    Basic Information

    Device Name
    PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
    K Number
    K954331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pall Biomedical Products Co.
    Date Received
    September 15, 1995
    Decision Date
    January 9, 1997
    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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