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

    40 MICRON BLOOD TRANSFUSION FILTER

    K Number: K941628 · Decision Feb 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    97
    Applicant Total
    19
    Review Days
    318

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    Basic Information

    Device Name
    40 MICRON BLOOD TRANSFUSION FILTER
    K Number
    K941628
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Douglas Medical Products Corp.
    Date Received
    April 4, 1994
    Decision Date
    February 16, 1995
    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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