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510(k) Data Aggregation

    K Number
    K210987
    Device Name
    IRRIGO Wound Wash Jet System
    Manufacturer
    Inopro Inc
    Date Cleared
    2022-05-31

    (425 days)

    Product Code
    FQH, FRO
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inopro Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IRRIGO Wound Wash Jet System is intended for use by or under the direction of a professional healthcare provider in moistening and lubricating absorbent wound dressings, cleansing, and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts, abrasions, and minor burns.
    Device Description
    IRRIGO Wound Wash Jet System is a sterile single patient use jet lavage medical device that consists of 0.9% USP Sodium Chloride solubilized in USP Purified Water for Irrigation and packaged in a food grade compressible translucent LDPE 2oz (60mL) bottle with a LPDE luer-lock type tip spray insert and an HPDE colored cap.
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