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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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