LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K112777
    Device Name
    SOL-M EXCHANGEABLE NEEDLES
    Manufacturer
    SOL-MILENNIUM MEDICAL, INC.
    Date Cleared
    2012-02-24

    (151 days)

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

    SOL-MILENNIUM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sol-M Exchangeable Needles are sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
    Device Description
    The Sol-M Exchangeable Needles are a sterile, single use, standard hypodermic needle. The device is available in 16 to 31 gauge and in lengths from 5/16" to 1-1/2". In addition, the needle tip is available in a regular or short bevel. Each needle device consists of a stainless steel cannula sealed with epoxy glue into a polypropylene hub. The assembly has a protective polypropylene needle cap/shield. The Sol-M Exchangeable Needles are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1