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P.E.S. & STRATUS 510(k) Application M T EXPERT K073556 JUN 2 4 2008 5 10(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN ACCORDANCE WITH SODA OF 1990 Date of Application: November 21, 2007, APPLICANT: Expert
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The 510k k073556 form is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device is safe and effective for its intended use.
Any manufacturer who intends to market a medical device in the United States is required to file the 510k k073556 form.
To fill out the 510k k073556 form, the manufacturer needs to provide detailed information about the medical device, its intended use, its technological characteristics, and any scientific evidence or testing conducted to demonstrate its safety and effectiveness.
The purpose of the 510k k073556 form is to demonstrate to the FDA that a medical device is substantially equivalent to a legally marketed device, or that it meets the requirements for a new device.
The 510k k073556 form requires manufacturers to provide information such as device description, intended use, technological characteristics, labeling, performance data, and any relevant clinical testing or scientific evidence.
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