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510(k) Data Aggregation

    K Number
    K081977
    Device Name
    PROSIT WOUND TREATMENT DEVICE
    Manufacturer
    SILVERLEAF MEDICAL PRODUCTS, INC.
    Date Cleared
    2008-12-01

    (143 days)

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

    SILVERLEAF MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For professional use, Procellera™ antimicrobial wound dressing is indicated for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites. For over-the-counter use, Procellera™ wound dressing is indicated for minor cuts, scrapes, irritations, and abrasions.
    Device Description
    Procellera™ is a single layer dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder. The polyester fabric is single ply and is made from multi-filament spun threads woven together. A small amount of current is produced and it occurs because it is inherent to the design. In the presence of exudate, the device should be used with an appropriate secondary barrier to maintain a moist wound healing environment.
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    K Number
    K060237
    Device Name
    CMB ANTIMICROBIAL DRESSING
    Manufacturer
    SILVERLEAF MEDICAL PRODUCTS, INC.
    Date Cleared
    2006-06-15

    (136 days)

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

    SILVERLEAF MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CMB Antimicrobial Dressing is indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns and donor and recipient graft sites.
    Device Description
    The CMB Antimicrobial dressing is a single layer dressing consisting of a woven adsorbent polyester containing elemental silver and zinc. In the presence of exudate, the dressing can be used with an appropriate secondary barrier to help maintain a moist wound healing environment.
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