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510(k) Data Aggregation

    K Number
    K971793
    Device Name
    VERY PRIVATE INTIMATE MOISTURE
    Manufacturer
    BRANDWYNNE CORP.
    Date Cleared
    1997-11-24

    (193 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This intimate moisture lotion is indicated to relieve vaginal dryness instance the pleasure of intimacy. It feels and functions like a woman's own moisture. It is NOT A CONTRACEPTIVE.

    Device Description

    Very Private® Intimate Moisture

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Very Private™ Intimate Moisture." This document is not a study report and therefore does not contain information about acceptance criteria, device performance, study design, or expert evaluations.

    The letter only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It specifies the product's regulatory class, product code, and indications for use.

    Therefore, I cannot provide the requested information as it is not present in the given text.

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