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510(k) Data Aggregation

    K Number
    K063401
    Device Name
    BANANA RIBBED
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Date Cleared
    2007-03-26

    (137 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BANANA RIBBED

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

    The BANANA Ribbed condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

    Device Description

    This condom is made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has smooth surface on the body, curve-sided, reservoir ended, straight six ribbed line at closed end, nominal length, width, thickness condoms with an integral bead at the open end.

    AI/ML Overview

    This document is a 510(k) summary for a male natural rubber latex condom. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of medical imaging software or AI. Instead, it describes the device, its intended use, and its substantial equivalence to predicate devices based on existing standards for rubber contraceptives.

    Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document focuses on regulatory approval for a condom, not the performance of an AI or software-driven medical device.

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