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

    PORT INFUSION SET (PIS) INFUSION SET (IS)

    K Number: K897065 · Decision Feb 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    7
    Review Days
    58

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    Basic Information

    Device Name
    PORT INFUSION SET (PIS) INFUSION SET (IS)
    K Number
    K897065
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Prn Services, Inc.
    Date Received
    December 20, 1989
    Decision Date
    February 16, 1990
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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