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510(k) Data Aggregation

    K Number
    K093227
    Device Name
    SILVERSTREAM AND DERMASEPT
    Manufacturer
    ENZYSURGE, LTD.
    Date Cleared
    2009-12-10

    (57 days)

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

    ENZYSURGE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prescription Use: SilverStream is intended for use under the supervision of a healthcare professional for management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, cuts abrasions and minor skin irritations Over-The-Counter Use: DermaSept is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas
    Device Description
    The SilverStream (prescription), and DermaSept (OTC) Solutions, are clear, hypertonic aqueous solutions designed for the management and moisturizing of the application site by the action of the fluid moving across the wound bed. The product is hypertonic and contains a surfactant. The SilverStream, and DermaSept, Solution contains an antimicrobial ionic silver, as a preservative, which has been shown, by in vitro testing, to inhibit the growth of microorganisms such as Eschericha coli, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae Pseudomonas aeruginosa, Candida albicans and Aspergillus niger.
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    K Number
    K060046
    Device Name
    DERMASTREAM
    Manufacturer
    ENZYSURGE, LTD.
    Date Cleared
    2006-02-27

    (52 days)

    Product Code
    NAD
    Regulation Number
    878.4020
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENZYSURGE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments such as irrigating solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and allow debridement to facilitate the normal wound healing process.
    Device Description
    The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments. It is provided as a sterile, single-use, disposable device.
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