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U.S. Department of Health and Human Services

Medical Devices

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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.



_____________________________

(Signature)

______________________________

(Typed Name)

______________________________

(Date)

_______________________________

*(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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