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510(k) Data Aggregation

    K Number
    K180731
    Device Name
    Ultramatrix EUS Balloon
    Manufacturer
    United States Endoscopy Group, Inc. (US Endoscopy)
    Date Cleared
    2018-04-19

    (30 days)

    Product Code
    ODG, ITX
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    United States Endoscopy Group, Inc. (US Endoscopy)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For endoscopic ultrasound applications using the balloon method in the upper or lower gastrointestinal tract.
    Device Description
    Not Found
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