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Who is required to submit a 510(k)?

Who is required to submit a 510(k)?

The regulations do not specify who must submit a 510(k) but they specify which actions require a 510(k) submission


Substantial Equivalence in 510(k)

Substantial Equivalence in 510(k)

Read and understand about Substantial Equivalence to protect your application.


510k Process Guide

510k Process Guide

Are you launching your device in the USA? Find out more about 510(k) requirements.