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510(k) Data Aggregation

    K Number
    K170003
    Device Name
    Zip 4 Skin Closure Device
    Manufacturer
    ZipLine Medical, Inc.
    Date Cleared
    2017-08-18

    (227 days)

    Product Code
    PYO
    Regulation Number
    880.5240
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZipLine Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zip 4 Skin Closure Device is indicated for skin closure of minor lacerations. The Zip 4 Skin Closure Device may be sold direct to consumers (OTC).
    Device Description
    The Zip® 4 Skin Closure Device is a single-use non-invasive skin closure device. A single Zip 4 device may be used to close wounds up to 4 cm (1.5 inches) in length from minor cuts or minor lacerations. The device is applied to clean, dry skin prior to skin closure, remains on the skin during wound healing, and may be removed by lifting one edge and peeling the device from the skin. The device is made of polymeric materials and utilizes a non-latex, pressure sensitive skin adhesive. The device contents are provided sterile in an intact and unopened package.
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