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510(k) Data Aggregation

    K Number
    K972522
    Device Name
    ML-DISPOSABLE PAK
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    1997-09-30

    (85 days)

    Product Code
    MSR
    Regulation Number
    886.4150
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in cataract surgery to irrigate and aspirate cataract material.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but this document contains general regulatory correspondence from the FDA regarding a 510(k) submission for a medical device called "ML-Disposable Pak." It explicitly states that this is an "Indications For Use Statement" for a device used in cataract surgery to irrigate and aspirate cataract material.

    This document DOES NOT contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or any of the other specific items you've requested.

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

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