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510(k) Data Aggregation

    K Number
    K991667
    Device Name
    BROADLINE OR TOWELS
    Manufacturer
    BROADLINE MEDICAL INDUSTRIES
    Date Cleared
    1999-09-27

    (136 days)

    Product Code
    KKX, DAT
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    BROADLINE MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is composed of 100% natural cotton fiber. The intended uses of an operating room towel are the absorption of fluids, including blood and body fluids while being used as patient drape at the incision site, or serving as a general use sterile towel for drying hands. The product is intended for single use and is disposable. This product is not intended to be used as a protective barrier.
    Device Description
    This device is composed of 100% natural cotton fiber.
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    K Number
    K990584
    Device Name
    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
    Manufacturer
    BROADLINE MEDICAL INDUSTRIES
    Date Cleared
    1999-04-23

    (59 days)

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

    BROADLINE MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended uses of gauze sponges are absorption of blood and body fluids, wound dressing, prepping and scrubbing, and debridement. This product is patient contacting material.
    Device Description
    GAUZE SPONGES
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