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SEP 2 2008GE Medical Systems Server
510 (k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted in accordance
with the requirements of 21 CFR
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What is this summary of 510k?
This summary of 510k is a document that provides a brief overview of a medical device submission to the FDA for marketing clearance.
Who is required to file this summary of 510k?
Manufacturers of medical devices seeking marketing clearance from the FDA are required to file this summary of 510k.
How to fill out this summary of 510k?
The summary of 510k can be filled out by providing detailed information about the medical device, its intended use, technological characteristics, and any clinical data supporting its safety and effectiveness.
What is the purpose of this summary of 510k?
The purpose of this summary of 510k is to demonstrate to the FDA that the medical device is substantially equivalent to a legally marketed device and meets applicable regulatory requirements.
What information must be reported on this summary of 510k?
The summary of 510k must include information about the device description, indications for use, technological characteristics, performance testing, labeling, and any relevant clinical data.
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