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510(k) Data Aggregation

    K Number
    K072921
    Device Name
    DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
    Manufacturer
    SYMBIOS MEDICAL PRODUCTS, LLC
    Date Cleared
    2007-11-26

    (42 days)

    Product Code
    MEB,BSO,KGZ
    Regulation Number
    880.5725
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM

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

    The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a presely for post-operative pain management.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a Food and Drug Administration (FDA) letter regarding the 510(k) premarket notification for the "GOPump Rapid Recovery System, Disposable Infusion Pump Kit." This document is a regulatory approval letter and does not contain the acceptance criteria or the study details that would demonstrate the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on the regulatory classification and approval process, not on the technical performance studies of the device.

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