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510(k) Data Aggregation

    K Number
    K082208
    Device Name
    DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
    Manufacturer
    SCIVOLUTIONS, INC.
    Date Cleared
    2008-12-01

    (118 days)

    Product Code
    NAC
    Regulation Number
    878.4018
    Why did this record match?
    Product Code :

    NAC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Doctors choice bandage with spray on remover is intended for prescription use in the local management of pressure sores as prescribed by a medical professional.
    Device Description
    The SciVolutions, Doctors Choice slow healing bandage is comprised of three products. The first is a premium gauze bandage with a non-stick net bottom side and a hydropholic breathable, waterproof polyurethane film membrane top side. The second device is a nonstick hydrocolloid bandage with the same polyurethane film membrane top side. Both of these bandage types are packaged for general use or diabetic use, with the only difference being the carton and carton labeling. The third product is the spray on remover, which may be used with both products.
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