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510(k) Data Aggregation

    K Number
    K981905
    Device Name
    STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291
    Manufacturer
    Date Cleared
    1998-08-18

    (78 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACU-PAK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ACU-PAK Sterile Saline Solution 0.9% / Sterile Water are used in health care facilities for the irrigation of general medical devices. It is used as a lubricant for suction catheters.
    Device Description
    ACU-PAK Sterile Saline Solution 0.9% and Sterile Water are used for the irrigation of medical devices. The device consists of 100ml of Saline Solution at a concentration of 0.9% or Water contained within a 100cc polyethylene wide mouthed bottle. The closure is a 38/400 white polypropylene cap fitted with an F 217 liner. A printed tamper-evident band is placed over the top of the bottle. Each bottle contains a product label displaying a lot code and expiration date.
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