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510(k) Data Aggregation

    K Number
    K991478
    Device Name
    TENDER TOUCH SILICONE GEL PADS
    Manufacturer
    CAPITAL MARKETING TECHNOLOGIES, INC.
    Date Cleared
    1999-06-21

    (54 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAPITAL MARKETING TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENDER TOUCH™ Silicone Gel Pads are designed to be worn on the body to help reduce pressure and friction against bony prominences, and they can also be used as scar management. This is not a wound covering or dressing and is not sterile.
    Device Description
    TENDER TOUCH™ Silicone Gel Pads are soft silicone gel sheets that are applied over bony prominences. The sheets are not made of medical grade silicone and are not sterile. The sheets are square and rectangular and come in three sizes, 9cm x 9 cm, 6 cm x 6 cm and 3.5 cm x 6 cm. They are approximately .125 of an inch thick. The customers will determine which size sheet is best for their own application. The pad helps reduce friction and pressure against the skin. They can also be used as scar management. The sheets are not for use on an open wound, are not sterile but can be washed. They can be used under casting and splints and can be cut to other shapes if necessary.
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    K Number
    K984213
    Device Name
    NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
    Manufacturer
    CAPITAL MARKETING TECHNOLOGIES, INC.
    Date Cleared
    1999-04-14

    (141 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAPITAL MARKETING TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NEARLY NETOUCHTMY Stillcone Scar Reduction Sheets are Soft durable silicone sheets designed to be worn on the skin for linited periods of time to reduce the appearance of hyp scars.
    Device Description
    RETOUCH™ Silicone Scar Reduction Sheets are soft, slightly adherent silicone gel sheets that are applied over healed hypertrophic and/or keloid scars. The sheets are not made of medical grade silicone and are not sterile. The sheets are rectangular and come in three sizes, 3.5 cm x 7 cm, 7 cm x 10.5 cm and 10.5 cm x 14 cm. They are approximately .125 of an inch thick. The customers will determine which size sheet is best for their own application. A sheet will not remove or eliminate the scar but will flatten and soften the scar tissue and help improve and regain the natural skin color. The sheets are not for use on an open wound, are not sterile but can be washed. They are to be temporarily used on old or new healed hypertrophic or keloid scars and can be cut to other shapes if necessary.
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