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510(k) Data Aggregation

    K Number
    K993395
    Device Name
    REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
    Manufacturer
    REMED PHARMA
    Date Cleared
    2000-02-15

    (130 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 Double Whooper Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Double Whooper Condom has a ribbed and dotted surfaced, contoured shape with reservoir end, it is used for contraception and to help prevent the transmission of sexually transmitted diseases.

    Device Description

    The Remed Preventor Double Whooper Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Double Whooper Condom has a ribbed and dotted surfaced, contoured shape with reservoir end.

    AI/ML Overview

    This is a 510(k) clearance letter from the FDA for a condom. It does not contain the information requested about acceptance criteria and study details for a medical device's performance. The document explicitly states: "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA."

    Therefore, I cannot provide the requested information based on the provided text.

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