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

    250 ML BAG W/Y INJECT. & 12 EXTENSION SET

    K Number: K882598 · Decision Nov 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    7
    Review Days
    130

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    Basic Information

    Device Name
    250 ML BAG W/Y INJECT. & 12 EXTENSION SET
    K Number
    K882598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Prn Services, Inc.
    Date Received
    June 24, 1988
    Decision Date
    November 1, 1988
    Product Code
    FRN
    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
    FRN Pump, Infusion

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    Other Clearances by Prn Services, Inc.

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    K897065 PORT INFUSION SET (PIS) INFUSION SET (IS)
    K884053 PRN PLUS + INFUSION SET
    K875155 60 ML RESERVOIR BAG, ITEM #200
    K860222 70 ML RESERVOIR BAG AND ADMINISTRATION SETS