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LIES 2005 9 DEC EXHIBIT I Z05 2 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SODA 1990 and 21 CFR 807.92. The
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What is this summary of 510k?
This summary of 510k is a concise overview of a medical device submission to the FDA for clearance to market.
Who is required to file this summary of 510k?
Medical device manufacturers are required to file this summary of 510k.
How to fill out this summary of 510k?
The summary of 510k is filled out by providing necessary information about the medical device being submitted for FDA clearance.
What is the purpose of this summary of 510k?
The purpose of this summary of 510k is to provide the FDA with information about the medical device to determine if it is safe and effective for use.
What information must be reported on this summary of 510k?
The summary of 510k must include details about the device, its intended use, technological characteristics, and any differences from similar devices already on the market.
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