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510(k) Data Aggregation

    K Number
    K063340
    Device Name
    SAF-T-SYRINGE- 0.5 AND 1ML/CC
    Date Cleared
    2007-03-06

    (120 days)

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

    SAFETY MEDICAL INTERNATIONAL, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Saf-T-Syringe is a sterile, single-use, disposable safety syringe with an auto-retracting needle is intended for injection of insulin subcutaneously. The retractable needle withdraws into plunger body after completion of injection and reduces the risk of accidental needle sticks injuries during use. The Saf-T-Syringe is a sterile, single-use, disposable, safety syringe with an auto-retracting needle and is intended for injection of allergy testing fluid and tuberculin. The retractable needle withdraws into plunger body after completion of injection and reduces the risk of accidental needle sticks injuries during use. The Saf-T-Syringe is a sterile, single-use, disposable, safety syringe with an auto-retracting needle and is intended for withdrawal of fluids and injection of fluids below the surface of the skin. The retractable needle withdraws into plunger body after completion of injection and reduces the risk of accidental needle sticks injuries during use.
    Device Description
    Not Found
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    K Number
    K051762
    Device Name
    SAF-T-SYRINGE/SAF-T-NEEDLE
    Date Cleared
    2005-09-23

    (85 days)

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

    SAFETY MEDICAL INTERNATIONAL, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Saf-T-Syringe's primary intended use is to provide a safe, accurate and reliable method of injecting medication into a patient. The syringe is available in a 3cc, 5cc and 10cc with various needle sizes. The needle automatically withdraws and prevents accidental needle sticks. 3cc, 5cc, and 10cc Syringes are available for: Prescription Use
    Device Description
    The Saf-T-Syringe is a 3cc, 5cc, and 10cc, sterile, non-toxic, non-pyrogenic, disposable, one-hand operated, passively activated, automatic retraction, plunger type, Anti-Stick syringe with a unique, dedicated luer-lock hypodermic needle, as detailed within this submission and in relevant patents. The syringe includes an interchangeable needle; 18 gauge to 25 gauge and lengths of 5/8", 1" and 1-1/2". The primary intended use of the device is to administer safe and accurate subcutaneous and intramuscular injections. Its secondary intended use is to retract and contain the contaminated needle after injection which renders the syringe inoperable for reuse, while not introducing any additional steps to the one-handed operating method, for the purpose of aiding in the prevention of accidental needle stick injuries.
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