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510(k) Data Aggregation

    K Number
    K960955
    Date Cleared
    1996-05-22

    (72 days)

    Product Code
    Regulation Number
    878.4200
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These drains are used in conjunction with non-powered single patient, portable suction apparatus. The drains provide a means to conduct fluids from a surgical wound via suction drainage.

    Device Description

    The Jackson-Pratt Gold™Wound Drains are made of polyvinyl chloride or silicone in a variety of sizes and are offered sterile.

    AI/ML Overview

    I am sorry, but after carefully reviewing the provided document, I could not find information about "acceptance criteria and the study that proves the device meets the acceptance criteria". The document focuses on providing general information about the Jackson-Pratt Gold™ Wound Drains, including its manufacturer, regulatory contact, trade name, classification, predicate devices, description, and intended use. It does not contain details about specific studies, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

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