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510(k) Data Aggregation

    K Number
    K083531
    Device Name
    LIQUIBAND ULTIMA, MODEL LB0004
    Manufacturer
    MEDLOGIC GLOBAL LTD.
    Date Cleared
    2009-02-12

    (76 days)

    Product Code
    MPN
    Regulation Number
    878.4010
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDLOGIC GLOBAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LiquiBand® Topical Skin Adhesive is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges. LiquiBand Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
    Device Description
    LiquiBand Topical Skin Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. LiquiBand Topical Skin Adhesive is supplied in a single patient use 0.5g High Density Polyethylene ampoule with polypropylene applicator tip.
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