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510(k) Data Aggregation

    K Number
    K091133
    Device Name
    APLION TOPICAL CARE SYSTEM
    Manufacturer
    APLION MEDICAL,LLC
    Date Cleared
    2009-05-20

    (30 days)

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

    APLION MEDICAL,LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.
    Device Description
    An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gasses such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing (21 CFR 878.4020). The Aplion Topical Care System ("Aplion System") consists of an occlusive wound dressing, a tubeset connection, and a small fluid-delivery component.
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