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510(k) Data Aggregation

    K Number
    K131177
    Device Name
    SINUFLUSH LAVAGE SYSTEM
    Manufacturer
    HEDGEPATH, LLC
    Date Cleared
    2013-09-20

    (148 days)

    Product Code
    KAR
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEDGEPATH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SinuFlush Lavage System is intended for nasal and sinus irrigation in patients who are under the care of a physician. The SinuFlush Lavage System is a prescription use product that is to be used by adults in either the physician's office or in the home after obtaining instructions from a health care provider.
    Device Description
    The SinuFlush Lavage System is a hand held 25 cc syringe with a plunger to control the force of delivery and volume markings on its side in order to measure the amount of irrigant to be delivered. The tip consists of soft silicone to occlude the nasal ostium during irrigation. The mixing container consists of a 25 cc container with markings on its side for volume measurement in cc, and a plastic screw top to secure the contents of the container during shaking.
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