Get the free 510(k) Number (if known) - fda
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There is no 510(k) form; however, 21 CFR 807 Subpart E describes ... The legally marketed device(s) to which equivalence is drawn is commonly known as the ... Finished device manufacturers must submit
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What is 510k number if known?
The 510k number refers to the unique identification number assigned to a medical device submission reviewed by the US FDA.
Who is required to file 510k number if known?
Manufacturers or distributors of medical devices are required to file a 510k number with the US FDA.
How to fill out 510k number if known?
To fill out the 510k number, the manufacturer or distributor needs to submit a complete application to the US FDA, including all required documentation and information.
What is the purpose of 510k number if known?
The purpose of the 510k number is to demonstrate that a new medical device is substantially equivalent to a legally marketed device and can be safely and effectively used.
What information must be reported on 510k number if known?
The 510k submission must include detailed information about the device, its intended use, as well as any clinical data, performance testing, and labeling.
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