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Re: BETTIEMAC post# 64987

Thursday, 12/03/2015 8:14:28 AM

Thursday, December 03, 2015 8:14:28 AM

Post# of 330593
" Just because the 510K was submitted on 8/6/2015 doesn't mean it was placed on FDA schedule for review. "

Friend, regardless of when the review started. The FDA website clearly states they will communicate the status of the application at 100 days after the submission date. The FDA will provide written explanation as to to why a decision was not made.

BIEL knows the reason why a decision has yet to be made...they are just not telling anyone.