FDA 510 (k)

FDA 510(k) is the technical documentation that is required to be able to place a medical device on the US market. It is a manufacturers responsibility to submit a 510(k) and it must include information on the testing and details of similarities and differences to an existing device. The team at Cranage Veritas can assist with your technical documentation and testing procedures for your medical device, in preparation for sale on the US market.

For more information on FDA 510 (k) talk to Cranage Veritas