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510(k) Data Aggregation

    K Number
    K061788
    Device Name
    BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
    Manufacturer
    BOEHRINGER LABORATORIES
    Date Cleared
    2006-07-11

    (15 days)

    Product Code
    OMP,JCX
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K060277,K042134,K052456
    Predicate For
    K080897
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Boehringer Laboratories Suction Pump System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation fluids, body fluids and infectious materials.

    Device Description

    The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the application of suction to wounds and for fluid removal. Disposables for use with the pump include: canister, Tube Attachment Device, Cover and Wound Contact Dressing

    AI/ML Overview

    This document is a 510(k) summary for the Boehringer Laboratories Suction Pump System. It establishes substantial equivalence to predicate devices and does not describe any specific acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on performance testing against specific acceptance criteria.

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