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510(k) Data Aggregation

    K Number
    K072560
    Device Name
    ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
    Manufacturer
    TEIKOKU PHARMA USA, INC.
    Date Cleared
    2008-06-17

    (280 days)

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

    TEIKOKU PHARMA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - For use in the management of psoriasis and the protection of psoriatic plaques - As a protective dressing - For management of superficial, dry to lightly exudating dermal wounds.
    Device Description
    Envela™ is substantially similar in terms of component materials, shape, dimensions, and mode of action to existing occlusive wound dressings.
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