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510(k) Data Aggregation

    K Number
    K103781
    Device Name
    MED-LOK SAFETY NEEDLE
    Manufacturer
    Date Cleared
    2011-02-08

    (43 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    STA-MED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Med-Lok™ Safety Needle device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
    Device Description
    Med-Lok™ Safety Needles
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    K Number
    K093176
    Device Name
    MED-LOK
    Manufacturer
    Date Cleared
    2010-04-06

    (180 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    STA-MED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Med-Lok™ Safety Needle Device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
    Device Description
    The Med-Lok is a hypodermic needle with protection device that allows full use of the needle and covers the needle after use to help prevent needle sticks and touch contamination.
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