A device may not be marketed in the U.S. until the submitter receives a letter finding the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:
resubmit another 510(k) with new data,
request a Class I or II designation through the De Novo Classification processfile a reclassification petition,
orsubmit a premarket approval application (PMA).
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| Open | High | Low | Value | Volume |
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| No. | Vol. | Price($) |
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