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510(k) Data Aggregation

    K Number
    K990749
    Device Name
    SOF-SUCTION FLUID EVACUATION SYSTEM
    Date Cleared
    1999-04-02

    (25 days)

    Product Code
    Regulation Number
    886.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    X-TECH MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sof-Suction™ Fluid Evacuation System is used to remove excess irrigation fluids The Bot-Baction - Pland 24 assumed aring microscopic eye surgery to mitigate the effects n of the medial cannies of the eye aid as a see and to prevent stagnant irrigating fluid from entering the eye
    Device Description
    Consists of a proximal portion consisting of a 11 mm x 7 mm x 7 mm polyvinyl acetal sponge tip fastened by heat bonding to a 7 mm 18Ga thin wall 301 stainless steel cannula friction attached to a 36'' 5 Fr polyvinyl acetate suction tubing, attached with medical grade adhesive to a ¼" standard suction tubing adapter. Included with the device is adhesive tape for fixating the suction tubing.
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