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510(k) Data Aggregation

    K Number
    K190144
    Device Name
    MucoPEG
    Manufacturer
    SunBio, Inc.
    Date Cleared
    2019-11-05

    (280 days)

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

    SunBio, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MucoPEG™ is indicated to relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness.
    Device Description
    MucoPEG™ is an artificial saliva to relieve xerostomia symptoms and discomfort. The main ingredient of MucoPEG™ is a polyethylene glycol (PEG) derivative. The additives to MucoPEG™ are mint (for flavor) and sodium bicarbonate (for pH maintenance when dissolved in water). MucoPEG™ is formulated as a powder and packaged in a single-use packet.
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