Premarket Notification Truthful And Accurate Statement
[As Required by 21 CFR 807.87(k)]
I certify that, in my capacity as (the position held in company) of
(company name), I believe to the best of my knowledge, that all data
and information submitted in the premarket notification are truthful and
accurate and that no material fact has been omitted.
*(Premarket Notification [510(k)] Number)
*For a new submission, leave the 510(k) number blank.
Must be signed by a responsible person of the firm required to
submit the premarket notification [e.g., not a consultant for the