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510(k) Data Aggregation

    K Number
    K153138
    Device Name
    Cerdak Basic
    Date Cleared
    2017-06-23

    (602 days)

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

    **BU POLYSCIENCES EQUIPMENT **& TRADING, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For the management of the following: Minor Cuts Minor Abrasions Minor Lacerations Minor Burns (1st degree burns)
    Device Description
    Cerdak™ is a single-use, sterile, bio-compatible device made of Aluminum Oxide ceramic granules in a non-woven fabric sachet. Cerdak™ dressing is provided in four configurations, they are: Basic, Aerofilm, Aerocloth and Drydoc and in several sizes ranging from 15mm X 25mm to 100mm X 250 mm. CERDAK™ covers and provides moist wound environment.
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