We ourselves(our company) and the vendor have an establishment registration and listing. We would be listed as the relabeler, reprocessor, distributor etc for device importing in to United States and the vendor would be listed as the manufacturer.
I also understand the 510K ownership to work as follows:
? If we own the 510K the vendor is not allowed to use that 510k for other distributors.
? If the vendor owns the 510K, he can use the 510K with any number of distributors.
? If another distributor of the vendor owns the 510K, we cannot use it unless authorized.
With that said, how is this enforced? How is our 510K protected so other distributors do not use it? Are the 510K numbers actually checked to determine which parties are using it? Where is it checked? How often is it checked? Does misuse occur?
Please guide me on the above.
I also understand the 510K ownership to work as follows:
? If we own the 510K the vendor is not allowed to use that 510k for other distributors.
? If the vendor owns the 510K, he can use the 510K with any number of distributors.
? If another distributor of the vendor owns the 510K, we cannot use it unless authorized.
With that said, how is this enforced? How is our 510K protected so other distributors do not use it? Are the 510K numbers actually checked to determine which parties are using it? Where is it checked? How often is it checked? Does misuse occur?
Please guide me on the above.