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510(k) Data Aggregation

    K Number
    K982435
    Device Name
    IRRIGATION SYRINGE KIT
    Manufacturer
    SUB-Q, INC.
    Date Cleared
    1998-11-06

    (116 days)

    Product Code
    KYZ
    Regulation Number
    880.6960
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IRRIGATION SYRINGE KIT

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

    The SUB-Q, Inc. Irrigation Syringe Kit is intended to be used in body cavities and wound sites to irrigate or deliver general wound management materials, such as saline, and other FDA cleared solutions.

    Device Description

    Irrigation Syringe Kit

    AI/ML Overview

    This document is a 510(k) clearance letter for an "Irrigation Syringe Kit" and does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the provided text.

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