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Re: bankrupt_2009 post# 135616

Tuesday, 05/08/2018 2:37:26 PM

Tuesday, May 08, 2018 2:37:26 PM

Post# of 330700
No PMA here. Worst case scenario 90 days for a 510K. But, with the circumstances this should go much much faster. This is the whole point of the meeting with the FDA. If I were the FDA, I will grant them clearance at the door steps along with a medal of excellence.