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510(k) Data Aggregation

    K Number
    K983478
    Device Name
    ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
    Manufacturer
    ORGANIC ESSENTIALS
    Date Cleared
    1998-11-09

    (38 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANIC ESSENTIALS

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

    Organic Essentials Organically Grown Cotton Tampon is a tampon that is inserted into the vagina and used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.

    Device Description

    Organic Cotton Tampon

    AI/ML Overview

    This is a letter about the clearance of the Organic Essentials Organic Cotton Tampon, a Class II medical device. The provided text is a 510(k) clearance letter and an "Indications for Use" statement.

    Unfortunately, this type of document does not contain the information requested in your prompt regarding acceptance criteria, study results, sample sizes, ground truth establishment, or expert qualifications.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria like those described in your prompt.

    Therefore, I cannot extract the requested information from the provided text.

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