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SEP PIM S.A.S. Zone industrially 61500 SEES France SECTION 5 510(k) SummarEliteTe ch Clinical Systems CHOLESTEROL HOL SL 2G Introduction Ai, 3 1 2011 According to the requirements of 21 CFR 807.92,
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How to fill out section 5 - 510k
How to fill out section 5 - 510k:
01
Provide a brief description of the device that you are seeking clearance for.
02
Include any applicable information on the device's intended use and intended user population.
03
Ensure that you provide a comprehensive list of any similar devices that are currently on the market.
04
Include a detailed summary of any performance testing that has been conducted on the device.
05
Provide information on any labeling or instructions for use that will accompany the device.
06
If applicable, include any information on clinical studies or investigations that have been conducted with the device.
07
Finally, make sure to include any additional information or supporting documents that may be relevant to the review process.
Who needs section 5 - 510k:
01
Medical device manufacturers who are seeking clearance from the U.S. Food and Drug Administration (FDA) to market their device in the United States.
02
Companies or individuals who have developed a new medical device or have made modifications to an existing device that may require clearance.
03
Regulatory affairs professionals and consultants who specialize in navigating the FDA clearance process and ensuring compliance with applicable regulations.
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