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510(k) Data Aggregation

    K Number
    K982673
    Device Name
    JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM
    Manufacturer
    KEY WEST FRAGRANCE & COSMETIC
    Date Cleared
    1998-10-29

    (90 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    **KEY WEST FRAGRANCE **& COSMETIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Key West Fragrance & Cosmetic Factory, Inc. Just Between Us™ Personal Lubricant & Condom convenience kit is intended to enhance the comfort and ease of intimate activity. The personal lubricant is compatible with latex condoms. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases .
    Device Description
    The Just Between Us™ Personal Lubricant and Condom kit is a non-sterile convenience kit that provides a latex condom and a personal lubricant separately wrapped in the same outer package. The condom is legally manufactured and marketed pursuant to 510(k) K910550 by the London International Corporation. Key West Fragrance & Cosmetic Factory, Inc. will manufacture the personal lubricant. The personal lubricant is nonstaining, water-soluble, glycerine and water based lubricant containing Aloe Vera Gel.
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