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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.

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This document is a 510(k) premarket notification decision letter from the FDA for several Saf-T-Syringe products. It does not contain information about acceptance criteria or a study proving device performance against acceptance criteria. The document only states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given text.

The information I would need to answer your request would typically be found in a Premarket Approval (PMA) application, a De Novo request, or detailed clinical study reports, which are not part of this 510(k) notification.

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