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510(k) Summary of Safety and Effectiveness:
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Telephone No.:AUG 1 6 2012Toshiba America Medical Systems, Inc.
PO Box 2068,2441 Michelle Drive Austin, CA 9278 12068
Charlemagne
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What is 510k summary of safety?
The 510k summary of safety is a document submitted to the FDA as part of the 510k premarket notification process for medical devices. It summarizes the safety information of the device.
Who is required to file 510k summary of safety?
Manufacturers of medical devices seeking FDA approval through the 510k process are required to file a summary of safety.
How to fill out 510k summary of safety?
The 510k summary of safety should include a detailed description of the device, its intended use, safety data, and any relevant clinical studies.
What is the purpose of 510k summary of safety?
The purpose of the 510k summary of safety is to provide the FDA with essential safety information about the medical device to ensure its safety and effectiveness.
What information must be reported on 510k summary of safety?
The 510k summary of safety should include information on the device design, materials, testing, labeling, and any known safety issues.
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