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510(k) Data Aggregation

    K Number
    K984345
    Device Name
    AROMAPATCH
    Manufacturer
    ENVIS, INC.
    Date Cleared
    1999-03-19

    (105 days)

    Product Code
    LRD
    Regulation Number
    874.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aromapatch™ nasal inhaler shall be single use only and are to be used by the general public as a medium for aroma inhalation of essential oils, such as eucalyptus oil.
    Device Description
    Aromapatch™ nasal inhaler
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