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510(k) Data Aggregation

    K Number
    K964120
    Device Name
    INJECTO FLUSH
    Date Cleared
    1996-12-30

    (76 days)

    Product Code
    Regulation Number
    876.1075
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROBERT J. JYNCH, JR.

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

    The Injecto Flush was designed to give a more practial and consistsnt way of flushing out reusable biopsy forcepts and canulated instruments.

    Device Description

    The Injecto Flush was designed to give a more practial and consistsnt way of flushing out reusable biopsy forcepts and canulated instruments. The Injecto Flush was also designed to have no effect on on the break down of instrumentation nor any possibility of cross contamination. The Injecto Flush is a one time disposable, but totally recyclable flushing unit.

    AI/ML Overview

    I apologize, but the provided text "DEC 30 1996 SUMMARY The Injecto Flush was designed to give a more practical and consistent way of flushing out reusable biopsy forceps and cannulated instruments... 9" is a product description for a medical device called "Injecto Flush" and doesn't contain any information about a study, acceptance criteria, device performance, sample sizes, expert qualifications, or any of the other specific details requested in your prompt.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

    To answer your request, I would need a text that describes a study evaluating the Injecto Flush device, including details about its performance, the methodology of the study, and the criteria used to deem it successful.

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