Medical Devices

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].







 

J-1

Page Last Updated: 05/20/2015
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