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510(k) Data Aggregation

    K Number
    K990253
    Device Name
    SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
    Manufacturer
    Date Cleared
    1999-09-24

    (240 days)

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

    AMBA MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Securline Operating Room Drape is a drape accessory made of synthetic material intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.
    Device Description
    The Securline Operating Room Camera Drape, Model #3600 is a drape accessory made of synthetic material.
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