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510(k) Data Aggregation

    K Number
    K062753
    Device Name
    FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC
    Manufacturer
    SURGIMED, INC.
    Date Cleared
    2007-02-08

    (147 days)

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

    SURGIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To inject fluids into or withdraw fluids from the body. For Injection of Insulin U-100 only.
    Device Description
    The FORSURE™ Disposable Syringes with Needle are Single Use, Sterile, Non-Pyrogenic devices used to inject fluids into or withdraw fluids from the body.
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