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510(k) Data Aggregation

    K Number
    K991757
    Device Name
    NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
    Manufacturer
    FURLONG INDUSTRIES
    Date Cleared
    1999-08-12

    (80 days)

    Product Code
    EFQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FURLONG INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices, both sterile and non sterile, are indicated for external use only and are intended to be used to clean wounds, to scrub or prepare incision sites, to absorb fluids, and dress wounds.
    Device Description
    Furlong Industries' Non-X-Ray Detectable Gauze Sponges/Bandages, both sterile and non sterile, consist of cotton, rayon or rayon/polyester formed material and/or cellulose. This device is for externation of conly for cleaning wounds, scrubbing, dressing and fluid absorption.
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