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510(k) Data Aggregation

    K Number
    K143444
    Device Name
    SynePure Wound Cleanser
    Manufacturer
    Synedgen Inc.
    Date Cleared
    2015-08-21

    (262 days)

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

    Synedgen Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.
    Device Description
    SynePure is a biocompatible, cleansing solution that is intended for rinsing and cleansing dermal wounds through irrigation. The solution is preserved and provided in flexible low density polyethylene (LDPE) bottles with a nozzle spray top to allow for easy delivery of a stream of liquid to remove dirt, debris and contamination from a wound. A screw cap is used to secure the device when not in use. The cap/bottle assembly is sealed with a strip to indicate tampering. The wound cleanser is supplied as 125mL single-use or 250mL multiple-use bottle. The mechanical action of fluid moving across the wound provides for the mechanism of action to aid in the removal of foreign objects, such as dirt and debris, from the wound.
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