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510(k) Data Aggregation

    K Number
    K993389
    Device Name
    REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
    Manufacturer
    REMED PHARMA
    Date Cleared
    2000-08-18

    (315 days)

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

    REMED PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Remed Preventor Banana Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Banana Tutti Frutti condom is a parallel sided, plain surfaced condom with banana 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 Banana Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Banana Tutti Frutti condom is a parallel sided, plain surfaced condom with banana flavor and no color additives.
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    K Number
    K993403
    Device Name
    REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
    Manufacturer
    REMED PHARMA
    Date Cleared
    2000-08-18

    (315 days)

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

    REMED PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Remed Preventor Strawberry Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry 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 Strawberry Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry flavor and no color additives.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMED PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    REMED PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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    K Number
    K993396
    Device Name
    REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
    Manufacturer
    REMED PHARMA
    Date Cleared
    2000-02-15

    (130 days)

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

    REMED PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Remed Preventor Extra Strength Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Extra Strength condom is a parallel sided, extra strong, plain surfaced condom with no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.
    Device Description
    The Remed Preventor Extra Strength Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Extra Strength condom is a parallel sided, extra strong, plain surfaced condom with no color additives.
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    K Number
    K993404
    Device Name
    REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT
    Manufacturer
    REMED PHARMA
    Date Cleared
    2000-02-15

    (130 days)

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

    REMED PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Remed Preventor Classic Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Classic is a parallel sided, plain surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.
    Device Description
    The Remed Preventor Classic Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Classic is a parallel sided, plain surfaced condom with no color additives.
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    K Number
    K993405
    Device Name
    REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
    Manufacturer
    REMED PHARMA
    Date Cleared
    2000-02-15

    (130 days)

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

    REMED PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Remed Preventor Dotted Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Dotted condom is a dotted surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.
    Device Description
    Remed Pharma Male Dotted Condom is a dotted surfaced condom with no color additives.
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    K Number
    K993408
    Device Name
    REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT
    Manufacturer
    REMED PHARMA
    Date Cleared
    2000-02-15

    (130 days)

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

    REMED PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Remed Preventor Ribbed Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Ribbed condom is a ribbed surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.
    Device Description
    The Remed Preventor Ribbed Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Ribbed condom is a ribbed surfaced condom with no color additives.
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    K Number
    K993390
    Device Name
    REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT
    Manufacturer
    REMED PHARMA
    Date Cleared
    2000-02-14

    (129 days)

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

    REMED PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Remed Preventor Super Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Super Condom has a ribbed and dotted surfaced, contoured shape with reservoir end, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.
    Device Description
    The Remed Preventor Super Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Super Condom has a ribbed and dotted surfaced, contoured shape with reservoir end.
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