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510(k) Data Aggregation

    K Number
    K152538
    Device Name
    JRP Wound Spreader
    Manufacturer
    J.R. PARKER, LLC
    Date Cleared
    2016-04-13

    (222 days)

    Product Code
    GAD
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    J.R. PARKER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JRP Wound Spreader is a non-invasive superficial wound retractor with integrated guard that is used for wound care and positioning of small superficial wounds in the skin of up to 1/4" in width, 1/4" in depth and 1/2" in length.
    Device Description
    The JRP Wound Spreader is a manually operated handheld non-invasive superficial wound retractor with an integrated guard that can accommodate a needleless syringe for the purpose of facilitating the retraction, observing the wound and flushing of small superficial wounds in the skin if deemed necessary. The JRP Wound Spreader consists of an array of four small tensioning fingers, which can be positioned on the skin astride a small superficial wound or incision.
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