If applicable, supply the FDA establishment registration number of the owner or operator submitting the premarket notification. Registration is not required in order for a company to submit a 510(k); however, it is a good idea to obtain one. This can be accomplished by filing a Registration Form 2891 with FDA. If this form is already being processed, or if the company intends to register in the future, mention the fact in the notification.
If applicable, include the registration numbers and addresses of each facility used to manufacture the finished devices, including contract sterilizers. The manufacturing process at each facility must be essentially the same, and produce the same device as described in the premarket notification submission.