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JUN 1 5 2004 510(k) Summary Applicants name address, phone and fax: Vanderbilt University Contact persons name and address: Michael Stalin Vanderbilt University 1161 21st Avenue South Nashville, TN
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510k is a premarket submission made to the FDA to demonstrate that a medical device is safe and effective.
Manufacturers, including importers and device re-packers, are required to file a 510k submission if they intend to market a medical device in the United States.
To fill out a 510k submission, manufacturers must provide information about the device's intended use, performance characteristics, and any clinical or non-clinical testing conducted.
The purpose of the 510k submission is to demonstrate that a medical device is at least as safe and effective as a legally marketed device.
The 510k submission must include information about the device, its intended use, its design, its labeling, and any scientific or clinical data supporting its safety and effectiveness.
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