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510(k) Data Aggregation

    K Number
    K070117
    Device Name
    SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
    Date Cleared
    2007-08-06

    (206 days)

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

    DOLOMITE BIOTECH SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Safe Plus Disposable Safety Syringe is an ETO sterile, non-toxic, non-pyrogenic, latex free, single-use, non-reusable, disposable manual retractable safety syringe in which medication can be injected into or fluid withdrawn from the human body. This device aids in prevention of needle stick injuries and reuse of the needle.
    Device Description
    The Safe Plus Disposable Syringe is a single use hypodermic syringe similar to a traditional syringe in application and function except for its safety mechanism which when activated: 1. completely retracts and encloses the needle in the barrel thereby preventing finger access 2. renders the needle unusable again as it is crushed within the puncture resistant barrel.
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