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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002 December 18, 2015,
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What is 510k premarket notification traditional?
510(k) premarket notification is a process to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device (predicate device).
Who is required to file 510k premarket notification traditional?
Manufacturers planning to market a medical device in the US are required to file a 510(k) premarket notification traditional.
How to fill out 510k premarket notification traditional?
To fill out a 510(k) premarket notification traditional, manufacturers must provide information on the device, intended use, performance data, and comparisons to predicate devices.
What is the purpose of 510k premarket notification traditional?
The purpose of 510(k) premarket notification traditional is to demonstrate that a new device is substantially equivalent to a legally marketed device, ensuring its safety and effectiveness.
What information must be reported on 510k premarket notification traditional?
The information that must be reported on a 510(k) premarket notification includes device description, intended use, performance data, comparisons to predicate devices, and labeling.
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