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510(k) Data Aggregation

    K Number
    K141603
    Device Name
    Ultra Silver Dressings
    Manufacturer
    MILLIKEN HEALTHCARE PRODUCTS, LLC
    Date Cleared
    2014-10-22

    (128 days)

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

    MILLIKEN HEALTHCARE PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
    Device Description
    The ULTRA Silver Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 4 layers, each performing a specific function; an occlusive synthetic top layer, a polyurethane foam layer, a hot-melt adhesive and a layer of a silver-containing knitted composite fabric.
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    K Number
    K110715
    Device Name
    INTERDRY SILVER
    Manufacturer
    MILLIKEN HEALTHCARE PRODUCTS, LLC
    Date Cleared
    2011-11-04

    (234 days)

    Product Code
    FRL
    Regulation Number
    880.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLIKEN HEALTHCARE PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterDry Textile is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile reduces microbial colonization in the fabric.
    Device Description
    InterDry is a non-sterile skin protectant fabric with an antimicrobial silver complex. InterDry is a single patient use product that is custom cut from a multiuse package.
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    K Number
    K103141
    Device Name
    LOW ADHERENT AFM AG DRESSINGS
    Manufacturer
    MILLIKEN HEALTHCARE PRODUCTS, LLC
    Date Cleared
    2011-01-21

    (88 days)

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

    MILLIKEN HEALTHCARE PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Low Adherent AFM Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
    Device Description
    The Low Adherent AFM Ag Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are designed to contact the wound as a primary dressing and permit the passage of fluids. The dressings provide a protective environment for the wound and an effective protection against microbial contamination in the dressing. The devices are effective antimicrobial barrier dressings against both Gram-positive and Gram-negative bacteria, including the following organisms: methicillin-resistant Staphylococcus aureus (MRSA). methicillin- resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant Enterococcus faecalis (VRE), Pseudomonas aeruginosa, and Acinetobacter baumannii.
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