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The document outlines the 510(k) premarket notification for the Apnea Guard, a mandibular repositioning device designed to reduce or alleviate snoring and mild to moderate obstructive sleep apnea
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What is jul 2 2 510k?
A jul 2 2 510k is a submission made to the U.S. Food and Drug Administration (FDA) for a premarket notification of a medical device.
Who is required to file jul 2 2 510k?
Any person or organization that wants to market a medical device in the United States is required to file a jul 2 2 510k.
How to fill out jul 2 2 510k?
To fill out a jul 2 2 510k, you need to provide information about the medical device, its intended use, performance data, and comparisons to similar marketed devices. The FDA provides specific guidance on how to complete the submission.
What is the purpose of jul 2 2 510k?
The purpose of jul 2 2 510k is to demonstrate that the new medical device is substantially equivalent to an existing device already legally marketed in the United States, or that it does not pose any significant risk to public health.
What information must be reported on jul 2 2 510k?
A jul 2 2 510k submission must include information such as device description, intended use, performance data, comparison to similar devices, proposed labeling, and any clinical studies or data supporting the safety and effectiveness of the device.
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