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smooch

08/07/17 12:47 PM

#6763 RE: 21money21 #6756

The Acceptance Review result will be one of the following:
the 510(k) was accepted for substantive review; or
the 510(k) was not accepted for review (i.e., considered refused to accept or RTA); or
the 510(k) is under substantive review because FDA did not complete the acceptance review within 15 calendar days.