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510(k) Data Aggregation

    K Number
    K971549
    Device Name
    VMT SYSTEM
    Manufacturer
    TARGET HEALTH, INC.
    Date Cleared
    1998-10-05

    (525 days)

    Product Code
    LXV
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TARGET HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VMT™ System is designed for the evaluation of visuo-motor performance disturbances.
    Device Description
    The VMT™ System is provided as follows: a. Trade Name VMT™ System b. Common and Descriptive Name - Ataxiagraph
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    K Number
    K973271
    Device Name
    SKAR-KARE
    Manufacturer
    TARGET HEALTH, INC.
    Date Cleared
    1997-11-19

    (78 days)

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

    TARGET HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SKAR-KARE™ is indicated for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.
    Device Description
    SKAR-KARE™ is a device composed of an outer shell consisting of medical grade silicone sheets adherent to each other with a sealed internal component filled with medical grade silicone oil. It is a soft, semi-transparent rubbery device.
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    K Number
    K971009
    Device Name
    SCAR CARE
    Manufacturer
    TARGET HEALTH, INC.
    Date Cleared
    1997-07-29

    (131 days)

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

    TARGET HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For the management of hypertrophic or keloid scars. SCAR CARE™ is intended for use in the management of hypertrophic and keloid scars.
    Device Description
    SCAR CARE™ is a device composed of an outer shell consisting of medical grade silicone sheets adherent to each other with a sealed internal component filled with medical grade silicone oil. It is a soft, semi-transparent rubbery device.
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