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並前往https://www.nsf.org/newsroom_pdf/md_raps_rf_catch_up_510K.pdf

The “Catch-Up” 510(k)— A Submission Often Overlooked

A 510(k) to bring FDA up-to-date on non-significant changes implemented since the last. 510(k) clearance is often known within the medical device industry as a ...

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