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Siemens Medical Solutions USA, Inc. Ultrasound Division NOV 9 2005 ACU SON Cypress Ultrasound System Special 510(k) Submission SECTION 11 510(k) Summary of Safety and Effectiveness13 Sponsor Siemens
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What is 510k summary of safety?
The 510(k) summary of safety is a concise document that provides a summary of the safety and effectiveness data for a medical device.
Who is required to file 510k summary of safety?
Manufacturers of medical devices are required to file the 510(k) summary of safety with the FDA.
How to fill out 510k summary of safety?
To fill out the 510(k) summary of safety, manufacturers must provide a summary of the safety and effectiveness data for their medical device.
What is the purpose of 510k summary of safety?
The purpose of the 510(k) summary of safety is to provide the FDA with a summary of the safety and effectiveness data for a medical device.
What information must be reported on 510k summary of safety?
The 510(k) summary of safety must include information on the safety and effectiveness data for the medical device, as well as any relevant clinical data.
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