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

    HEMO-NATE SYRINGE BLOOD FILTER

    K Number: K781815 · Decision Feb 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    97
    Applicant Total
    1
    Review Days
    126

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    Basic Information

    Device Name
    HEMO-NATE SYRINGE BLOOD FILTER
    K Number
    K781815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Gisco Intl.
    Date Received
    October 24, 1978
    Decision Date
    February 27, 1979
    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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