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Found 5 results

510(k) Data Aggregation

    K Number
    K063401
    Device Name
    BANANA RIBBED
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Date Cleared
    2007-03-26

    (137 days)

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

    MEDTECH PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BANANA Ribbed condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    This condom is made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has smooth surface on the body, curve-sided, reservoir ended, straight six ribbed line at closed end, nominal length, width, thickness condoms with an integral bead at the open end.
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    K Number
    K012969
    Device Name
    DOUBLE SPRINGERS NONOXNOL 9 CONDOM
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Date Cleared
    2002-06-12

    (281 days)

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

    MEDTECH PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Double Springers Nonoxynol 9 condom, is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Not Found
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    K Number
    K993733
    Device Name
    LOVE LOCKERS
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Date Cleared
    2000-03-20

    (137 days)

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

    MEDTECH PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Love Lockers condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.
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    K Number
    K993735
    Device Name
    DOUBLE SPRINGERS
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Date Cleared
    2000-03-20

    (137 days)

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

    MEDTECH PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Double Springers condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.
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    K Number
    K993737
    Device Name
    MIGHTY MAN (DYNAMIC LINKERS)
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Date Cleared
    2000-03-20

    (137 days)

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

    MEDTECH PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mighty Man (Dynamic Linkers) condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.
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