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Re: IMGGorBust post# 25306

Wednesday, 09/01/2010 6:35:24 PM

Wednesday, September 01, 2010 6:35:24 PM

Post# of 59576
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.
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