Bust
Does the FDA base the 150 day period on calendar days? If so, then this Friday (8/3) would be exactly 147 days (or 21 weeks) from the 4/9 date that the FDA acknowledged receiving the 510-K, which would make Monday, 8/6 (a holiday), exactly 150 days.
Assuming the FDA is trying to meet that 150 day period, would that mean they would try to issue approval by this Friday? I realize this is an arbitrary time period, but was curious as I respect your opinions. TIA.