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510(k) Data Aggregation

    K Number
    K031432
    Device Name
    KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
    Manufacturer
    HK SURGICAL, INC.
    Date Cleared
    2003-08-07

    (93 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Klein Surgical Infiltration Pump, Model KIP-II. It does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, sample sizes, or expert qualifications as requested in the prompt.

    This type of FDA letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not typically include the detailed study results that would be found in a comprehensive submission document or scientific publication. Answering the prompt would require information not present in the provided text.

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