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Found 4 results
510(k) Data Aggregation
K Number
K980019Device Name
HTL MALE CONDOM
Manufacturer
REDDY MEDTECH HEALTH PRODUCTS LTD.
Date Cleared
1998-04-01
(89 days)
Product Code
HIS
Regulation Number
884.5300Why 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
K974323Device 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
884.5300Why 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
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K Number
K974324Device 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
884.5310Why 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
K974326Device Name
LATEX CONDOMS (NATURAL COLOUR)
Manufacturer
REDDY MEDTECH HEALTH PRODUCTS LTD.
Date Cleared
1998-02-09
(83 days)
Product Code
LTZ
Regulation Number
884.5310Why 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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