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MAR 6 2014 10. 510(K) SUMMARY This summary of safety and effectiveness information is being submitted in accordance with the requirements of SODA 1990 and 21CER 807.92. The Assigned 5 10(k) number
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What is 510k summary this summary?
The 510k summary is a summary of the safety and effectiveness information provided in a premarket notification submission for a medical device.
Who is required to file 510k summary this summary?
Manufacturers of medical devices seeking to market their device in the United States are required to file a 510k summary.
How to fill out 510k summary this summary?
To fill out a 510k summary, manufacturers must provide detailed information on the safety and effectiveness of their medical device, including comparisons to existing devices on the market.
What is the purpose of 510k summary this summary?
The purpose of a 510k summary is to demonstrate that a medical device is as safe and effective as similar devices already on the market, and therefore does not require premarket approval from the FDA.
What information must be reported on 510k summary this summary?
Information that must be reported on a 510k summary includes device description, performance data, materials, design, and intended use.
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