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510(k) Data Aggregation

    K Number
    K103587
    Device Name
    DISPOSABLE BLLOD COLLECTION NEEDLE
    Date Cleared
    2011-04-06

    (120 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    WEIHAI HONGYU MEDICAL DEVICES CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable Blood Collection Needles is designed for use in the daily blood collection routine when delegated by a qualified practitioner.
    Device Description
    Blood collection needle is a sterile and disposable medical device. It is consist of a puncturing needle which is punctured into vein, a bottle needle which is insert to the blood collection bottle to collect blood, a needle holder which connects the puncturing needle and bottle needle, two needle caps which protect puncturing needle and bottle needle and a latex cover to protect bottle needle.
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