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510(k) Data Aggregation

    K Number
    K980019
    Device Name
    HTL MALE CONDOM
    Manufacturer
    REDDY MEDTECH HEALTH PRODUCTS LTD.
    Date Cleared
    1998-04-01

    (89 days)

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

    REDDY MEDTECH HEALTH PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. including chlamydia infections, genital herpes, genital warts, gonorrhea. hepatitis B, and syphilis. Condoms when properly used are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.
    Device Description
    HTL Male Latex Condom, Natural Color, Silicone Lubricated
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    K Number
    K974323
    Device Name
    LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT
    Manufacturer
    REDDY MEDTECH HEALTH PRODUCTS LTD.
    Date Cleared
    1998-02-10

    (84 days)

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

    REDDY MEDTECH HEALTH PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.
    Device Description
    Latex Condoms, Natural Color with Silicone Oil Lubricant
    Ask a Question
    K Number
    K974324
    Device Name
    LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT
    Manufacturer
    REDDY MEDTECH HEALTH PRODUCTS LTD.
    Date Cleared
    1998-02-09

    (83 days)

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

    REDDY MEDTECH HEALTH PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.
    Device Description
    Not Found
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    K Number
    K974326
    Device Name
    LATEX CONDOMS (NATURAL COLOUR)
    Manufacturer
    REDDY MEDTECH HEALTH PRODUCTS LTD.
    Date Cleared
    1998-02-09

    (83 days)

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

    REDDY MEDTECH HEALTH PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.
    Device Description
    Latex Condom, Colored, with Spermicidal Lubricant
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