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510(k) Data Aggregation

    K Number
    K022959
    Device Name
    SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
    Manufacturer
    MDC RESEARCH LTD.
    Date Cleared
    2003-02-05

    (152 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDC RESEARCH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SafeStep™ Safety Dental Cartridge Injector is a sterile, single use disposable injector barrel assembly and a reusable plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges and existing screw-on dental needles for injection of anesthetic solution in oral tissues. The SafeStep™ Safety Dental Cartridge Injector aids in the prevention of needle stick injuries. The SafeStep™ Safety Dental Cartridge Injector incorporates a needle retraction and re-advancing mechanism which may be operated with one hand.
    Device Description
    The SafeStep™ Safety Dental Cartridge Syringe consists of a single-use, disposable aspirating syringe-type injector with a separate re-usable plunger assembly indicated for the use in delivering dental anesthetics. The SafeStep™ Safety Dental Cartridge Syringe incorporates a needle safety mechanism that can be activated with one hand.
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    K Number
    K973012
    Device Name
    MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM
    Manufacturer
    MDC RESEARCH LTD.
    Date Cleared
    1997-11-05

    (84 days)

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

    MDC RESEARCH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A properly placed MDC Safe Step Safety Blood Collection Needle System incorporates a retractable needle safety mechanism to minimize needle stick injuries when used to access a vein to obtain blood samples.
    Device Description
    The Safe Step Safety Blood Collection Needle System consists of four separate components: a blood collection needle assembly; an evacuated tube adapter; a front protective cap; and a rear protective cap. The Safe Step Safery Blood Collection Needle System is a standard Blood Collection Needle System with the additional feature of a retractable needle. The needle safety mechanism can be activated by lifting the thumb pad (located on the rear piece of the tube adapter) upwards and forward, relative to the two finger tabs on the tube adapter front piece, after removing the last blood sample tube. After needle retraction, the device is disposed of according to routine procedure in a sharps container.
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    K Number
    K960013
    Device Name
    MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM
    Manufacturer
    MDC RESEARCH LTD.
    Date Cleared
    1996-02-13

    (42 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDC RESEARCH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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