Forum > General > What Is FDA 510K Submission & How Does 510K Consultant Help With The Same?

Posted by Thomas Regulatory on February 13, 2023


FDA 510k Consultant assist you in navigating the entire Class I, Class II, and Class III device approval process by thoroughly understanding the device and identifying any potential hazard. Qualified and experienced technical experts ensure 510k clearance promptly. A 510(k) is a premarket submission to the FDA that demonstrates that the device to be marketed is as safe and effective as a legally marketed device (section 513(i)(1)(A) FD&C Act).

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