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  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. Premarket Notification 510(k)
  7. Premarket Notification Truthful And Accurate Statement
  1. Premarket Notification 510(k)

Premarket Notification Truthful And Accurate Statement

[As Required by 21 CFR 807.87(l)]


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.






(Typed Name)




*(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

510(k) submitter].



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