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510(k) Data Aggregation
(135 days)
YI XIN STERILE SYRINGE FOR SINGLE USE
YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.
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The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about the acceptance criteria, device performance, study design, or specific results of a study as requested in the prompt. The letter confirms that the device, "YI XIN Sterile Syringe For Single Use," is substantially equivalent to predicate devices and can be marketed.
Therefore, I cannot provide the requested information based on the given input.
To answer your request, I would need a scientific report, clinical trial results, or a summary of performance testing for the device.
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