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510(k) Data Aggregation

    K Number
    K022614
    Device Name
    INVIGRA
    Manufacturer
    INDUS MEDICARE LTD.
    Date Cleared
    2003-04-08

    (245 days)

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

    INDUS MEDICARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invigra Condom is used for contraception and for prophylactic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
    Device Description
    Invigara Male Latex Condom, Lubricated and Black Colored
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    K Number
    K020223
    Device Name
    INVIGRA
    Manufacturer
    INDUS MEDICARE LTD.
    Date Cleared
    2002-03-04

    (41 days)

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

    INDUS MEDICARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invigra Condom is used for contraception and for prophylactic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
    Device Description
    Invigra - Male Natural Rubber Latex Condom
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    K Number
    K000038
    Device Name
    INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
    Manufacturer
    INDUS MEDICARE LTD.
    Date Cleared
    2000-03-21

    (75 days)

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

    INDUS MEDICARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000039
    Device Name
    INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
    Manufacturer
    INDUS MEDICARE LTD.
    Date Cleared
    2000-03-21

    (75 days)

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

    INDUS MEDICARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000040
    Device Name
    INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
    Manufacturer
    INDUS MEDICARE LTD.
    Date Cleared
    2000-03-21

    (75 days)

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

    INDUS MEDICARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K993693
    Device Name
    INVIGRA
    Manufacturer
    INDUS MEDICARE LTD.
    Date Cleared
    1999-12-29

    (57 days)

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

    INDUS MEDICARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invigra Condom is used for contraception and for prophylactic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HTV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
    Device Description
    Invigra - Male Natural Rubber Latex Condom
    Ask a Question
    K Number
    K992438
    Device Name
    INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
    Manufacturer
    INDUS MEDICARE LTD.
    Date Cleared
    1999-08-02

    (11 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDUS MEDICARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invigra Plus condom is used for contraception and for prophytic purposes. Invigra Plus Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphliss. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
    Device Description
    Invigra Plus (With Spermicidal Lubricant) - Male Natural Rubber Latex Condom
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    K Number
    K991374
    Device Name
    INVIGRA
    Manufacturer
    INDUS MEDICARE LTD.
    Date Cleared
    1999-06-15

    (55 days)

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

    INDUS MEDICARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invigra Condom is used for contraception and for prophytic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphliss. contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
    Device Description
    Not Found
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