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510(k) Data Aggregation

    K Number
    K052720
    Device Name
    MEDLINE IODOFORM PACKING STRIPS
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2005-10-20

    (21 days)

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

    MEDLINE IODOFORM PACKING STRIPS

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

    Medline Iodoform Packing strips are intended for use for general wound packing.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a No Objection Letter from the FDA for a medical device called "Medline Iodoform Packing Strips." It explicitly states that the device is "substantially equivalent" to legally marketed devices and can proceed to the market.

    However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The letter is a regulatory document confirming market clearance, not a clinical study report. Therefore, I cannot extract the requested information based on the input provided.

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