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510(k) Data Aggregation

    K Number
    K081246
    Device Name
    TT-102
    Manufacturer
    TISSUE TECHNOLOGIES HOLDINGS, LLC
    Date Cleared
    2009-08-13

    (469 days)

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

    TISSUE TECHNOLOGIES HOLDINGS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TT-102 Wound Dressing is indicated for the management of: Diabetic ulcers, Venous ulcers, Pressure ulcers, Ulcers caused by mixed vascular etiologies, Full thickness and partial thickness wounds, Traumatic wound healing by secondary intention, Dehisced surgical wounds, Abrasions, Donor sites and other bleeding wounds
    Device Description
    TT-102 Wound Care Dressing is a highly absorbent, sterile, single-use primary dressing comprised of phosphorylated cellulose with ionically bound silver. The dressing prevents microbial colonization in the dressing.
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    K Number
    K061060
    Device Name
    TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8
    Manufacturer
    TISSUE TECHNOLOGIES HOLDINGS, LLC
    Date Cleared
    2006-07-03

    (77 days)

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

    TISSUE TECHNOLOGIES HOLDINGS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TT101 Wound Care Dressing is indicated for the management of exuding wounds including: Diabetic ulcers Venous ulcers Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds
    Device Description
    TT101 Wound Care Dressing is a sterile primary dressing comprised of phosphorylated cellulose, formed into a sheet approximately 3 mm thick cut into various size pieces. When placed on a wound, the dressing provides a moist wound environment that is supportive to wound healing.
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