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510(k) Data Aggregation

    K Number
    K993409
    Device Name
    REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
    Manufacturer
    REMED PHARMA
    Date Cleared
    2000-08-18

    (315 days)

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

    The Remed Preventor Coconut Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Coconut Tutti Frutti condom is a parallel sided, plain surfaced condom with coconut flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.

    Device Description

    The Remed Preventor Coconut Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Coconut Tutti Frutti condom is a parallel sided, plain surfaced condom with coconut flavor and no color additives.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a condom, and it does not contain the specific information required to answer the questions about acceptance criteria and a detailed study.

    Therefore, I cannot provide the requested information from this document.

    To answer your questions, I would need access to a study report or a different type of FDA submission that details the performance data and acceptance criteria for a medical device. This document primarily confirms that the device is substantially equivalent to a predicate device, allowing it to be marketed.

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